Pfizer

Pt states got Covid vaccine today ay 730am, shortly after started feeling dizzy and scratchy throat. She was sent to the ED. ED treated as follows: Solu-Medrol, Benadryl and Pepcid given intravenously. Patient was monitored in the emergency department for improvement of symptoms. Her throat fullness and pruritus resolved. She feels well and wishes to be discharged home. Pepcid, Benadryl and prednisone prescribed for treatment of any recurrence of allergic reaction symptoms that might occur when she is discharged. She will return to the hospital should symptoms worsen. She returned to the ED the next day and these are notes from that visit: 26-year-old female, past medical history significant for asthma and irritable bowel syndrome presents to the emergency department with complaint of allergic reaction. Patient states she took the Covid vaccine yesterday and with 8 minutes developed tightening in her throat and rash. She presented to the emergency department yesterday and was treated with Solumedrol, Pepcid and Benadryl which relieved her symptoms. She was discharged home with Pepcid Benadryl and prednisone however she has not taken the prednisone because she does not like how it makes her feel. She states this morning she developed tightness in her throat, nausea and felt as if she were going to pass out. She states when her symptoms began she took Pepcid and Benadryl but did not take any prednisone. Upon arrival she is very anxious, talking in complete sentences, no drooling noted 1241: EKG sinus tachycardia rate 111, PR 0.14, QRS 0.08, QT 0.30, no acute changes. Initial read by Dr. at 1243   1 L normal saline IV, Solu-Medrol 125 mg IV, Benadryl 25 mg IV and Ativan 1 mg IV for relief of symptoms. Patient verbalized that she felt her symptoms were combination of allergies uric reaction and anxiety. I have encouraged her to take the prescriptions as directed at her ER visit yesterday. Procedures   MDM   Return the emergency department new symptoms or concerns worsening of current condition.1241: EKG sinus tachycardia rate 111, PR 0.14, QRS 0.08, QT 0.30, no acute changes. Initial read by Dr. at 1243   1 L normal saline IV, Solu-Medrol 125 mg IV, Benadryl 25 mg IV and Ativan 1 mg IV for relief of symptoms. Patient verbalized that she felt her symptoms were combination of allergies uric reaction and anxiety. I have encouraged her to take the prescriptions as directed at her ER visit yesterday.  

At 2:56pm, associate complained of nausea, lightheadness. Blood pressure was elevated; 165/102; heart rate 98bpm; SPO2 99% on room air; Placed in supine position in observation area. Administered Benedryl 50mg oral at 3:25pm; Blood pressure was rechecked at 3:40pm; 141/91; heart rate 88; associated states she felt improved of all symptoms; associate has been cleared to return home; husband will transport

increased (rapid) heartrate at rest, an hour following administration of vaccine. Symptom persisted for half an hour, followed by flushing of the face and slight nausea.

I had a very sore arm; lightheadedness/dizziness; back ached; felt like I had the flu - body aches; felt like I had the flu - body aches; shivering/chills; nausea; fatigue; This is a spontaneous report from a non-contactable nurse (patient). A 26-year-old female patient received bnt162b2 (lot number: EH9899, brand=Pfizer-BioNTech), via an unspecified route of administration, at arm left, first dose on 16Dec2020 10:00, at single dose for COVID-19 immunization. No relevant medical history. No allergies to medications, food, or other products. Concomitant medication included ethinylestradiol, norgestimate (TRI-SPRINTEC), spironolactone (SPIRONOLACTONE) both from an unspecified date for unspecified indication. The patient is not pregnant at the time of vaccination. Age at vaccination was 26. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. About 12 hours after the COVID vaccine (also reported as from 16Dec2020 21:00), the patient suddenly felt like had the flu-body aches, shivering, nausea, fatigue, chills, but no fever. She went to bed and woke up the next morning (17Dec2020) feeling fine, except she had a very sore arm and was fatigued. Also had some lightheadedness/dizziness that second day and her back ached. No treatment was received for the adverse event. The events were reported as non-serious. The outcome of the events was recovered on an unspecified date. No follow-up attempts are possible. No further information is expected.

nausea; vomiting; This is a spontaneous report from a non-contactable nurse. A 26-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), Lot number: Ek9231, intramuscular on Left arm from 24Dec2020 13:45 to 24Dec2020 13:45 as single dose for COVID-19 immunization. Medical history included depression, anxiety, chronic migraine. Concomitant medication included duloxetine hydrochloride (CYMBALTA), ibuprofen, topiramate (TOPAMAX), bupropion hydrochloride (WELLBUTRIN). On 5Dec2020 05:45, the patient experienced nausea and associated vomiting approximately 16 hours after vaccination administration. The outcome of the events was recovered. No follow-up attempts are possible, information about batch number cannot be obtained.

I had nausea all day, heart rate over 120, pelvic & back pain, chills, normal temp of 98.6. Throughout the day my heart rate was at 125 even at sitting . My blood sugars were completely normal.

Shortness of breath; chest pain; body aches; joint pain; headache; nausea; congestion; This is a spontaneous report received from a non-contactable nurse (who is also the patient). A 26-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: El0140), intramuscular in right arm, on 29Dec2020 17:30, at single dose, for COVID-19 immunization. Medical history included spontaneous pneumothorax x2 on the right with VATS surgery on an unspecified date and multiple food allergies. The patient is not pregnant. Concomitant medication included montelukast sodium (SINGULAIR) and loratadine (CLARITIN). The patient experienced shortness of breath, chest pain, body aches, joint pain, headache, nausea and congestion, all on 30Dec2020 at 05:00. The patient did not receive treatment for the events. The patent did not receive any other vaccines within 4 weeks prior to BNT162B2. Prior to vaccination, it was unknown if the patient was diagnosed with COVID-19. Since vaccination, the patient has not been tested for COVID-19. The outcome of the events was recovering. The reporter assessed the case as non-serious. No follow-up attempts are possible. No further information is expected.

Went to the ER on the 31st, my face swelled and chest was covered in hives. Lips swelled. I would get nauseated and I felt like there was acid in my stomach. I also had a headache. I have been taking Zyrtec, Benadryl as needed.

fever 101.8 (resolved within 24 hours) lymphadenopathy (ongoing - submandibular, anterior/posterior/deep cervical) edema of soft tissues i throat on right side making it difficult to swallow SOB n/v/d

24 hours after vaccine, I had typical mild cold/flu symptoms. After 48 hours I had a lot of pain in my injection arm and my armpit lymph nodes were swollen. I treated the pain with Advil and a heating pad. 72 hours after the vaccine I felt faint, dizzy, and nauseous. I began to vomit and have diarrhea that entire night and next morning. I felt very weak and was unable to keep any foods or liquids down. I was unable to walk around. I took Zofran 8mg which helped with the severe nausea and weakness. These symptoms are ongoing.

About ten hours after the injection, started having severe chills, N/V, severe headache, dizziness, fever, severe muscle soreness, active loss of smell and taste. General malaise and weakness.

Arm pain at injection site; fever of 101; chills; severe body aches; mild headache; nausea; This is a spontaneous report from a contactable nurse. A 26-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot numbe: EK5730), via an unspecified route of administration on the left arm on 31Dec2020 10:00 at single dose for COVID-19 immunisation. Medical history included anxiety, and covid prior vaccination: Yes. Concomitant medication included sertraline hydrochloride (ZOLOFT). The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on an unspecified date. The patient experienced arm pain at injection site, fever of 101, chills, severe body aches, mild headache, nausea on 01Jan2021. The patient received no treatment. The outcome of the events was recovering. No follow-up attempts are possible. No further information is expected.

Headache Body ache Fatigue Painful soreness at the injection site Swollen lymph nodes on arm of injection site - painful sore ness Chest pain

Started with headache around 3pm the day after the vaccine administration. Took Advil around 4pm, with no relief. Nausea started shorty after eating dinner at 6pm. Around 7pm, went to bed and started getting chills and felt feverish (did not have thermometer to record temp). Napped for 3 hours and felt better after. Next morning, feeling milder headache.

a slight sore throat and cough with a slight fatigue; a slight sore throat and cough with a slight fatigue; body aches; chills; fatigue; mild fever; diarrhea; nausea; This a spontaneous report from a contactable nurse (patient). A 26-years-old female patient started to the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), lot number EJI685, unspecified route of administration on 30Dec2020 15:45 (at the age of 26-years-old) as 1 single dose in the right arm for COVID-19 immunization. Medical history included Polycystic ovarian syndrome (PCOS) and anxiety. Concomitant medication included ascorbic acid (VITAMIN C) colecalciferol (VITAMIN D), zinc and birth control. The patient was allergic to sulfamethoxazole and trimethoprim (BACTRIM) antibiotics. The most recent COVID-19 vaccine was administered in the hospital. The patient was not pregnant at the time of vaccination. Prior to vaccination, the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.The next morning after receiving the vaccine the patient had full body aches, chills, fatigue, mild fever, diarrhea, and nausea. These all resolved within 24 hours as the next day (2nd day after vaccination). The patient felt much better, and only had a slight sore throat and cough with very slight fatigue.The full body aches, chills, fatigue, mild fever, diarrhea, nausea, a slight sore throat and cough with a slight fatigue did not result in death, was not life-threatening, did not cause/prolonged hospitalization, was not disabling/incapacitating and did not cause congenital anomaly/birth defect. No treatment was received for the events full body aches, chills, fatigue, mild fever, diarrhea, nausea, a slight sore throat and cough with a slight fatigue. Outcome of the events full body aches, chills, fatigue, mild fever, diarrhea, and nausea was recovered. Outcome of the events a slight sore throat and cough with a slight fatigue was recovering. Since the vaccination, the patient has not been tested for COVID-19.

temperature of 101 °F; body aches; headache; nausea; chills; This is a spontaneous report from a contactable Other HCP (patient). A 26-year-old female patient started to receive BNT162B2 (Batch/lot number: EK9231) at right deltoid via an unspecified route of administration on 03Jan2021 12:20 at single dose for covid-19 immunisation. Medical history was none. The patient's concomitant medications were not reported. The patient experienced temperature of 101 °F, chills, body aches, headache and nausea on 04Jan2021 02:00. Patient stated for the second one, she was hoping for the best, but she got the vaccine yesterday (03Jan2021), at 12:20, and today (04Jan2021), at 2 AM, she had a temperature of 101, and chills, body aches, headaches, and nausea. She was out of it today, she was not feeling good, and was told to do this. Caller got the vaccine at Employee Health. After 4 hours of Tylenol (expiry is May2021, lot is P115252), her temperature went right back up. It was about 99 when she had Tylenol. Chills started late this morning (04Jan2021) and were ongoing when she was not on Tylenol, but her body aches were ongoing. 9AM was when her headache started, and she was intermittently on Tylenol, but if past the 4 hour mark, they were as bad as they were this morning, but with Tylenol they were better. Nausea was mostly this morning, and had gotten better. Patient stated that due to her current symptoms her employer had required her to be tested for COVID-19. She had not yet received the results of that test. Seriousness for events temperature of 101 °F, chills, body aches, headache and nausea was Medically significant. Lab data included COVID test on 23Dec2020 was negative. The outcome of temperature of 101 °F, headache and nausea was recovering; of body aches was not recovered; of chills was unknown. Primary Source Reporter (Method of assessment was Global Introspection) considered the events were related to BNT162B2.; Sender's Comments: There is a reasonable possibility that the events reported were related to BNT162b2 based on known drug safety profile and close temporal relationship. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.

Muscle and joint aches, nausea, chills. Worked 6am-1pm (went home early). Slept for 3 hours, no improvements. Hydrated, ate small dinner, went to bed. Woke up 4:45am for work and symptoms were gone.

Myalgias, joint aches, nausea, severe rigors and chills starting about 12 hours after administration of vaccine

4 hours after administration (1/8/21) I had nausea. The following day (1/9/21) I had a mild fever, body aches, headache, and was fatigued. These symptoms lasted until about 7pm until I took Tylenol. Once I took Tylenol I felt almost immediately better.

Within seconds increased heart rate shortness of breath light headedness and dizziness but thought it could have been anxiety. Did not say anything and sat there for the 15 minutes with continued shortness of breath and high rate think it was anxiety. When the time was up I continued to stay at the hospital for an hour due to fear of bad reaction. Started to become extremely nauseous within 30 minutes and loss of appetite. Went to bed and woke up with a terrible headache, body aches, extreme fatigue and a 100.3 degree fever. Slept for 8 hours during the day waking up due to the pain in my body and chills but the symptoms went away by 5 pm the following day of the shot.

Woke up at 1000 with severe body aches, sore neck, sore throat, mild headache, and nausea. Running a mild fever of 99.3F (baseline usually around 96.5-97.0). I took some Tylenol to elevate symptoms.

headaches, nausea, body aches, chills, sore throat, fatigue, light headedness approximately 12 hours after administration which continued for a few days after. Medicated with Ibuprofen to manage pain.

Vaccine Dose 1 12/17/2020: I received the vaccine and within 5 minutes I experienced dizziness, sweating and was flushed. After 15 minutes the dizziness did not go away and my vitals were checked. My BP was elevated 136/106 and HR 105, I was taken to the ED after repeated BP readings continued to show increased diastolic pressure. I was observed in ED for a period of almost 6 hours. Within an 1.5 hours after receiving vaccine, I had right neck stiffness, headache, and some weakness to the right side as well along with the dizziness and high BP. I received a 1L bolus of NS, 2 doses of antivert, Toradol, Zofran and Lidocaine patches. 24 hours after receiving vaccines, I was having pain at the insertion site, headache, neck stiffness and occasional dizziness. After 36 hours my symptoms subsided and I felt back to baseline. Vaccine Dose 2 01/07/2020: I received my second dose of the COVID vaccine and within the first 15 minutes I experienced dizziness, nausea, flashing spots in vision, right sided weakness, increased BP & HR, redness and sweating. After 30 minutes the symptoms did not subsided and I was taken to the ED. An hour after receiving the vaccine, I had right sided weakness to arm and legs with no numbness, dizziness, R. sided neck stiffness, right sided headache, nausea and flashing spots. I received Ativan, Reglan, Tylenol, Toradol and Benadryl in the ED. I was in ED for 3.5 hours after vaccines was administered and was able to ambulate to the car independently. 16 hours after receiving vaccine, I had muscle weakness to bilateral lower extremities and was unable to ambulate independently along with dizziness, headache, arm soreness, cough, congestion, neck stiffness and fatigue. 36 hours after vaccine I regained movement to bilateral lower extremities however still was experiencing fatigue, occasional dizziness, intermittent neck stiffness and headache, body aches and some shakiness to lower extremities. 55 hours after receiving vaccine I was still fatigued and experiencing intermittent headache and neck stiffness. 72 hours after vaccine I was still fatigued and having occasional headaches but feeling much much better from initial reaction. 96 hours after receiving vaccine I experienced occasional headache, woke up with neck stiffness and was finally able to drive a car without any dizziness or nausea. 144 hours after vaccine I am not completely back to baseline still fatigued with occasional neck stiffness and headache but able to go back to work.

2 episodes of vomiting; Pain/redness/tenderness/swelling injection site; Pain/redness/tenderness/swelling injection site; Pain/redness/tenderness/swelling injection site; Fever of 100.0; Chills; Extreme fatigue; Headache; Muscle aches; Nausea; This is a spontaneous report from a contactable other healthcare professional (patient). A 26-year-old female patient received 1st dose of BNT162B2 ((PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK5730), intramuscular in left arm on 18Dec2020 10:00 at single dose for COVID-19 immunisation. Medical history included covid-19 from Oct2020 to an unknown date. No known allergies. The patient was not pregnant. Concomitant medication included ethinylestradiol, norethisterone acetate (JUNEL FE 1/20). No other vaccine received in four weeks. The patient experienced fever of 100.0, chills, extreme fatigue, headache, muscle aches , nausea and pain/redness/tenderness/swelling injection site on 19Dec2020 13:00, 2 episodes of vomiting on 19Dec2020 23:45. Patient received tylenol as treatment. No COVID tested post vaccination. The patient underwent lab tests and procedures which included body temperature: 100.0 on 19Dec2020, Covid test: positive in Oct2020. The outcome of fever of 100.0, chills, headache, muscle aches was recovered on 20Dec2020, nausea was recovered on 21Dec2020, extreme fatigue and pain/redness/tenderness/swelling injection site was recovered on 22Dec2020, 2 episodes of vomiting was recovered on an unspecified date. This case was reported as non-serious.

24hrs after shot felt fine I til about 30hrs then felt lightheaded, dizzy, and nauseous. Vomited once. The next day (~42hrs after shot) spiked fever 101.2 and continued to feel dizzy but less nauseous. Took 800mg Motrin at 5am on 1/15/21

Injection site redness; rash on arm near injection site; fever in arm; chills; nausea; This is a spontaneous report from a contactable other health care professional. A 26-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; lot number: EJ1686), intramuscular on 31Dec2020 07:30 at single dose at arm left for COVID-19 immunization. Medical history included GERD, ovarian cysts, obesity, and anxiety. Concomitant medications included fluoxetine, omeprazole, and folic acid. On 11Jan2021 07:00, the patient experienced Injection site redness, rash on arm near injection site, fever in arm, chills, nausea. The patient did not receive treatment for the events. The outcome of the events was recovering.

Symptoms starts 9am with headache. For 3 times panadol q 4 hours 500mg. At 8pm start fever (40.2 C), nauseas, dizzines, shaking chills and lost smell. Vomiting starts at 9:25 pm end 2:00 am. 01/08/2021 at 2:26 am visit Emergency Room, in clinic fainted and present high blood pressure 155/99. In hospital medication administred: Zofran, pepcid, .45 NSS and Phenergan IM at 01-08-2021.

Diarrhea, nausea, body aches, stiff neck, low grade fever , fatigue . Happened 6 hours after injection ( this happened when I got my first one too)

I received the vaccine at 11:56AM on 1/15/2021. L arm injection site pain/tenderness which increased over the course of two days. At approximately 12:30AM on 1/16/2021, extreme nausea, vomiting, fever, chills, and muscle aches began. During the day on 1/16/2021 severe joint pain (specifically bilateral knees and hips, and spine) occurred, somewhat relieved by Tylenol. On 1/17/2021 at 1:15AM, intense nausea, vomiting, and fever occurred again. As of 9:15AM on 1/17/2021, body aches and joint pain are returning and nausea is persistent.

0845 received vaccine 1900 onset moderate headache 0100 felt feverish and nauseous 0400 nausea resolved 0700 feverish sensation resolved 1800 headache resolved

Received second dose of vaccination at approximately 4:50 PM. Awoke at 2:30 AM with mild fever, body aches, chills, and nausea. Got out of bed for to drink fluids; after walking around for approximately 10 to 15 minutes I experienced a blood pressure drop resulting in me passing out on my bathroom floor. Prior to passing out attempts to regulate breathing and placing head between my legs failed to keep me conscious. Unknown duration of time spent passed out on floor; eventually was able to walk back to bed upon waking and lying on floor for additional 5 minutes (conscious). Awoke again at 8 AM with mild fever, chills, and body aches, while experiencing mild drops in blood pressure (no nausea). Symptoms ceased the following day of 1/16/2020.

Tachycardia up to 150 resting; Nausea; Vomiting; Diarrhea; Headache; Migraine; Body aches; Chills; Fever up to 102; This is a spontaneous report from a contactable nurse (patient). This 26-year-old female patient (pregnant: no) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: EL3248), intramuscular on 08Jan2021 at 07:45 AM at single dose on right arm for COVID-19 immunisation. Medical history included anxiety and depression. No known allergies. Concomitant medication included fluoxetine hydrochloride (PROZAC), bupropion hydrochloride (WELLBUTRIN), diphenhydramine hydrochloride (ZZZQUIL). No other-vaccine-in-four weeks. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: EK5730), intramuscular on 22Dec2020 at 08:00 PM on right arm for COVID-19 immunisation. The patient experienced tachycardia up to 150 resting, nausea, vomiting, diarrhea, headache, migraine, body aches, chills and fever up to 102. Symptom onset around 7PM on 08Jan2021 and stopped around 12PM 09Jan2021 except for headache which was still persisting as of 9PM 09Jan2021. No treatment was received for the events. The outcome of headache was not recovered. The outcome of other events was recovered on 09Jan2021 at 12PM. The patient did not have COVID-prior-vaccination. The patient did not have COVID tested post vaccination.; Sender's Comments: The reported tachycardia was probably related to the use of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) due to temporal relationship. The case will be reassessed should additional information become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.

generalized body soreness.; severe migraine; severe weakness; left arm (same arm she received vaccine) broke out in a red itchy rash; red itchy rash; feeling hot; dry heaving; severe painful coughing; severe painful coughing lasted about an hour along with post nasal drip appearing; within 2 hours my skin became blotchy and itchy; within 2 hours my skin became blotchy and itchy; This is a spontaneous report from a contactable nurse (patient). A 26-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL0142 and expiry date: unknown), via an unspecified route of administration on the left arm on 05Jan2021 17:30 at a single dose for COVID-19 immunization. Medical history included autoimmune progesterone dermatitis, Reynaud's syndrome, skin mottling, gastrooesophageal reflux disease (GERD), migraines, post-traumatic stress disorder (PTSD), sulfa allergy, and depression. Patient was not pregnant. The patient's concomitant medications included PEPCID. The patient previously took progesterone, miconazole and hydroxychloroquine sulfate (PLAQUENIL) and experienced allergy.The patient experienced within 2 hours her skin became blotchy and itchy on 05Jan2021 18:45. She took a shower and symptoms resolved. Next morning on 06Jan2021, patient's left arm (same arm she received vaccine) broke out in a red itchy rash. She took Prednisone 40mg around 10am and rash resolved. Around 3-4pm the rash reappeared along with feeling hot on the same day. She ran outside and began dry heaving and coughing. The severe painful coughing lasted about an hour along with post nasal drip appearing on 06Jan2021. During that hour patient took Zofran,12 puffs of Albuterol total, and Benzedrex nasal spray. She was already on Pepcid 20mg- 2 tablets BID for GERD prior to reaction; cough improved. On 07Jan2021, around 2-3am morning woke up with a severe migraine and cough returned along with severe weakness. Patient went to the clinic she worked and received steroid shots to help along with Maxalt and more Albuterol. By Sunday, 10Jan2021, she was almost back to base like, generalized body soreness. Monday (11Jan2021) back to base line for the most part. The patient underwent lab tests and procedures which included nasal swab: negative on 08Jan2021. Outcome of the events was recovered with sequel. The reporter considered the events as non-serious. Patient was not diagnosed with COVID-19 prior to vaccination and had been tested since the vaccination.

Headache; Fever up to 100.5; Extreme fatigue; Muscle aches; Nausea; Lack of appetite; Immediate arm pain - swelling, tender to touch; Immediate arm pain - swelling, tender to touch; Immediate arm pain - swelling, tender to touch; This is a spontaneous report from a contactable Nurse. A 26-year-old female patient patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number EL3246) intramuscular, on 08Jan2021 at 16:00 on left arm at single dose for COVID-19 immunization. Relevant medical history included that patient had a Covid diagnosis on early October. Vaccination history included first dose of BNT162B2 (lot number: EK5730) on 18Dec2020 at 10:00 AM, Intramuscular on Left arm .Concomitant medication included ethinylestradiol, norethisterone acetate (JUNEL FE 1/20). The patient was not pregnant. On 08Jan2021 at 16:00 the patient experienced Immediate arm pain - swelling, tender to touch. On the same day at 22:00 the patient experienced Fever up to 100.5, extreme fatigue, muscle aches, nausea and lack of appetite. Treatment received included Tylenol. The patient recovered from Immediate arm pain - swelling, tender to touch on an unspecified date, from other reported events, recovered on 10Jan2021.

Jan 11th- by 11PM felt fatigue, muscle aches, febrile, nauseous, and chills. Jan 12th- Fatigue, soreness at injection site, and chills. Jan 13th- chills and fatigue. Jan 16th- febrile, body aches, and chills Jan 17th- febrile, fatigue, body aches and chills. Jan 18th- febrile, fatigue, body aches and chills Jan 19th- febrile, fatigue, body aches, chills, sore throat, left ear pain and nausea. Jan 20th- sore throat, body aches, fatigue, hives

Started with nausea, racing heart, and dizziness. Within a few minutes scratchy throat and Epi was administered along with O2 at that time. Sent to ER.

After the vaccination I began to suffer from SOB and tested positive for covid-19 on 12/29 and was given an enhaler to help with the breathing. I had a sore throat, fatigued, a headache and diarrhea

Itching; Nausea; Headache; Body ache; Site soreness and swelling; Site soreness and swelling; This is a spontaneous report from a contactable nurse. A 26-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EH9899), intramuscular in right arm, on 21Dec2020 at 19:45, at a single dose, for COVID-19 immunization. The patient's medical history included sciatica. The patient's concomitant medications were not reported. The patient had no known allergies to medications, food, or other products. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The facility where the most recent COVID-19 vaccine was administered was a hospital. After the first dose on 21Dec2020 (from the day of injection and for 2 days post), the patient experienced itching, nausea, headache, body ache, and site soreness and swelling. Treatment was received for the adverse events which included paracetamol (TYLENOL) at 500 mg. Since the vaccination, the patient has been tested for COVID-19. Polymerase chain reaction (PCR) nasal swab for COVID-19 that was negative on 04Jan2021. The patient recovered from the events in Dec2020. No follow-up attempts are possible. No further information is expected.

Pfizer COVID Vaccine; ADR developed after 5 min. Patient became lightheaded and developed tunnel vision. Had a witnessed syncopal event in her car. Unconcious x1 min, had urinary incontinence, and vomited; Not postictal; developed episode of tunnel vision few hours after 1st dose as well

Vomiting lasting 48 hours, Diarrhea lasting 7 days, muscle aches, fever lasting 7 days, lethargic 4 days

3 hours following vaccine: nausea, dizziness, and irritability 6 hours following vaccine: previous symptoms + headache (5 out of 10) and cold sweats 8 hours following vaccine: previous symptoms + widespread body aches (6 out of 10) Restless sleep punctuated by waking up with cold sweats or overheating. 24 hours following vaccine: previous symptoms persist. Headache and body aches have worsened in severity. Unable to work for the morning but was able to go in the afternoon for a short time period. Lower body aches are particularly severe. Fatigue is noticeable. Mental health conditions have worsened but that may be due to lack of sleep. 30 hours following the vaccine: chills, nausea, and dizziness have dissipated completely. They were slowly improving throughout the day. Body aches and headache still severe but lessened with marijuana use. 48 hours following the vaccine: all symptom seemed to have subsided during the night. Sleep was much better quality. Only remaining symptom is an ache on the right side of my chest towards my ribs.

Within five minutes I felt very faint and dizzy along with nausea. Then came the shortness of breath and the feeling of pins and needles which also brought itching and some minor hives with it. The dizziness, nausea, and feeling of fainting went away after about 10 minutes and I had to go to the Emergency Department to take care of the shortness of breath and hive like reaction. I was given some medications and they diagnosed it as a moderate allergic reaction to the vaccine. I was completely fine with the first one.

Dizziness 2 hours after vaccination, lasted up to 3 hours later. Chills and nausea 3 hours after vaccination, lasted 1-2 hours. Joint pain in hip 1 and 2 days after vaccination. Chills, fever, muscle fatigue 2 days after vaccination.

Muscle aches, headache, chills, nausea, diarrhea, chills, right arm pain, severe right armpit swelling (lymph node swelling).

As patient was waiting in waiting area approximately 5 minutes after receiving her 1st COVID vaccine, pt's friend called pharmacist over as patient felt she was about to faint. She had her eyes closed and said she felt faint. Notified incident command to call for provider. We moved her to an exam room so she could lie down. She said she felt warm and dizzy. Pt breathing heavily. Denied chest pain. Had stomach pain and some nausea. Pt was given water. ER provider arrived about 4:30 and listened to lungs, carotids, talked to patient regarding vasovagal reaction. Pt slowly began to feel better and was talking and laughing. Waited with patient until 4:50, able to stand on own, not dizzy anymore, felt okay to leave.

Dose Number:1/ Date of start of drug:22Dec2020 / Dose Number:2/ Date of start of drug: 08Jan2021; Serious chills to the point of physical shaking; serious chills to the point of physical shaking; Nausea; Vomiting; Dry heaving; Significant body aches, especially pronounced in lower back region occurred; Significant body aches, especially pronounced in lower back region occurred; Headache; Having sweats; Possible fever (didn't have thermometer to accurately verify this though); My average HR is usually 70's. For about 36 hours, it ran 100-130's; Dehydration; Feeling fatigued/Excessive fatigue; Had some general arm soreness; This is a spontaneous report from a contactable nurse (patient). A 26-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, Lot number: EJ 1686, unknown expiration), intramuscular in right arm on 08Jan2021 at 13:30 at a single dose for COVID-19 immunization in a hospital. The patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: EJ 1685, unknown expiration) via intramuscular in right arm on 22Dec2020 at 12:30 PM for COVID-19 immunization in a hospital. Concomitant medications included ibuprofen (MOTRIN) as needed and unspecified birth control. The patient has no known allergies. The patient started feeling fatigued about 1900 hours (07:00 PM) on 08Jan2021 and only had some general arm soreness. She woke up on 09Jan2021, with serious chills to the point of physical shaking; nausea started soon after and around 0300, began vomiting and dry heaving. The patient also experienced significant body aches, especially pronounced in lower back region occurred. Headache also present at this time (09Jan2021). She began having sweats and possible fever (didn't have thermometer to accurately verify this though). The patient's average HR is usually 70s. For about 36 hours (09Jan2021), it ran 100-130s. Vomiting episodes continued and for all of 09Jan2021, the patient did absolutely nothing. The patient described her body ached like it had been beaten by a baseball bat. On 10Jan2021, her HR at rest back in 70s, but with minimal exertion, will go to 110-120s. She had to call out of work from 11Jan2021 and 12Jan2021 due to continued nausea, dehydration and excessive fatigue. The patient did not receive other vaccine in four weeks. The patient did not have COVID prior to vaccination and was not tested for COVID post vaccination. The patient's symptoms still persisting at the time she is reporting this event. The patient did not receive treatment for the events. The outcome of the event "having sweats" was unknown, while the patient is recovering for the remaining events.; Sender's Comments: The reported serious chill was likely related to the BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) due to plausible temporal relationship and known safety profile of this product.

Approximately 12 hours after the administration of the second COVID19 Pfizer vaccine, I experienced chills and myalgia through the night. I did not improve when I woke up on 01/25. The chills and myalgia worsened and were complicated by vomiting without blood. I called off sick from work and took 3 Aleve tablets. I went back to sleep with improvement in symptoms approximately 6 hours later, with only mild myalgias and a very sore L. arm. Symptoms completely resolved by the morning of 01/26.

Fever; cold chills; Hot flashes; Nausea; Headache; increase body pain; This is a spontaneous report from a contactable other healthcare professional (patient). A 26-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiration date were not reported), intramuscularly on the left arm on 04Jan2021 11:00 at a single dose for COVID-19 immunization. Medical history included liver failure, mononucleosis, gallbladder disease, mitral regurgitation of the heart and fibromyalgia; patient had no known allergies. Concomitant medications were not reported. Patient did not have COVID prior vaccination, no other vaccine was given in four weeks prior and patient did not receive other medications within two weeks of the vaccine. The vaccine was given at a nursing home/senior living facility. On 04Jan2021, the patient experienced fever, cold chills, hot flashes, nausea, headache and increased body pain. Moderate side effects were also reported from 05Jan2021 to 09Jan2021. No treatment was given for the events. The patient underwent lab tests and procedures which included nasal swab COVID test: negative on 04Jan2021 and saliva swab test for COVID: pending result on 11Jan2021. Outcome of the events was recovering. Information on the lot/ batch number has been requested.

G2P0, 5w5d; The patient is calling with vaginal bleeding in pregnancy. Calling with c/o dizziness with headache; Has a history of migraines; States she has subclinical hypothyroidism. Has tried Tylenol 500 mg for headache that worked for a little while; She denies vomiting, but does have nausea; Will try to increase water and protein intake; Will let us know if she gets worse/vision changes and will check in with PCP as they wanted to do a VV if dizziness got worse. Bleeding continued into following day. Documented as likely / threatened miscarriage.

Sudden abdominal pain 12 hours after vaccination and vomiting.; Sudden abdominal pain 12 hours after vaccination and vomiting; This is a spontaneous report from a non-contactable consumer(patient). A 26-year-old female patient received first dose BNT162B2, via an unspecified route of administration at left arm on 11Jan2021 14:30 at single dose for COVID-19 immunization . Patient had other medications in two weeks. There was no other vaccine in four weeks. The patient medical history was not reported. There was no covid prior vaccination, no covid tested post vaccination, no Known allergies. The patient experienced sudden abdominal pain 12 hours after vaccination and vomiting on 12Jan2021 03:00 with outcome of recovering. There was no treatment received. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

Fatigue/severe body aches Fever of 100-101 degrees Chills/sweating Headaches Intermittent sore throat Intermittent nausea Elevated HR Has lasted two days after vaccination and caused me to miss work

I had a very sore arm which is normal, however the day after I received the vaccine I was extremely nauseous and I threw up 5x at 7:30 AM. I had a migraine the rest of the day and was extremely tired, sleeping a total of 19 hours.

severe pain in left arm/neck/rib; severe pain in left arm/neck/rib; severe pain in left arm/neck/rib; Nausea; body aches; Cold and hot flashes with rigors; Cold and hot flashes with rigors; Cold and hot flashes with rigors; significantly warm to touch; Fatigue; lethargy; site of pain; This is a spontaneous report from a contactable nurse (patient). A 26-year-old non-pregnant female patient received her second dose of bnt162b2 (BNT162B2 reported as PFIZER COVID-19 VACCINE; lot number: EL0142; expiration date: unknown), via an unspecified route of administration left arm on 04Jan2021 19:45 at a single dose for covid-19 immunization. Medical history included asthma and sulfa drug allergies. The patient was not diagnosed with Covid-19 prior to vaccination. Concomitant medication included albuterol [salbutamol] (ALBUTEROL), montelukast sodium (SINGULAIR) and vitamins nos (MULTIVITAMIN). The patient has not had other vaccine in four weeks. The patient received her first dose of bnt162b2 (BNT162B2 reported as PFIZER COVID-19 VACCINE; lot number: EK5730; expiration date: unknown), via an unspecified route of administration left arm on 16Dec2020 06:30 AM at a single dose for covid-19 immunization which had no reaction other than slight tenderness at injection site. The patient received her vaccine in a hospital. The patient reported that within approximately 12 hours of second dose, she had severe pain in left arm/neck/rib. The pain was spasm-like and tight. She mentioned that the nausea was related to periods of pain. The patient had cold and hot flashes with rigors. The patient mentioned that she did not have access to thermometer, but significantly warm to touch. The patient added that she has fatigue /lethargy and body aches. It was reported that the systemic symptoms resolved within 24 hours while the site pain. Interventions done by the patient included acetaminophen, ibuprofen and ice pack to site of pain. The patient has been tested post vaccination, a nasal swab which was negative on 06Jan2021. The outcome of the events was recovered on Jan2021.

Body aches, upset stomach, mild chills: lasted ~8hrs Headache: lasted ~12hrs Sore arm (injection site): ~42+hrs (still mild discomfort at this time)

Headache; chills; sweating; nausea; tonsil stones; muscle aches; This is a spontaneous report from a contactable other healthcare professional (reported for herself). A 26-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231), intramuscular (left arm) on 12Jan2021 (12:15 PM) at single dose for Covid-19 immunization. The patient received the first dose of BNT162B2 (lot number: EK9231) intramuscular (left arm) on 23Dec2020 (03:00 PM) for Covid-19 immunization. The patient's medical history included migraines and anemia; no known allergies. Concomitant medications included spironolactone, frovatriptan succinate, ethinylestradiol, norgestimate (TRI-SPRINTEC), and ferrous sulfate. The patient was not diagnosed with COVID-19 prior to vaccination. The patient is not pregnant. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced headache, chills, sweating, nausea, tonsil stones, and muscle aches on 13Jan2021 (07:00 AM). There was no treatment received for the adverse event. The outcome of events was recovering. The patient has not been tested for COVID-19 since the vaccination.

Severe headache, nausea, all-over muscle pain, joint stiffness, fatigue, temp went up but not enough for a fever. I took Bayer for the muscle pain and slept. Developed soreness of injection site approximately an hour after injection. Muscle stiffness and joint pain began that night. Other symptomst started Thursday morning and ended Friday morning.

Vomiting for 6 hours, severe nausea, high fever (103 first time, 102.6 second time) ringing in ears, tunnel vision.

Pfizer COVID-19 Vaccine EUA Student here for first dose of Pfizer Covid vaccine. Lot EL3249. States she waited in waiting area for 30 minutes post vaccine and that 15 minutes into the wait her throat started feeling scratch. She decided to leave without informing anyone of her symptoms and began walking home. On the walk home her throat began to get sore and she found it hard to swallow. She reported back to clinic with her s/s at ~1350. She was given Benadryl 25 mg, Pepcid 20 mg and Zyrtec po at 1400. BP-162/77, P-96, 98%. At 1420, BP-143/87, P75, 100%. Patient was instructed to consulted with an allergist before booster dose of Covid vaccine. At 1435 she reported her throat felt normal again.

Date of start of drug 18Dec2020/ Date of start of drug 12Jan2021; Date of start of drug 18Dec2020/ Date of start of drug 12Jan2021; Dizziness; nausea; fever; joint pain; body aches; throbbing headache x 24 hours; This is a spontaneous report from a contactable Nurse (patient). A 26-year-old female patient received BNT162b2 BNT162b2 (lot number: EL3246) second dose on 12Jan2021 on Right Arm at single dose for covid-19 immunization. Medical history included Headaches of an unknown origin. Concomitant medications were not reported. No covid prior vaccination. No covid tested post vaccination. No Known allergies. Facility type vaccine was Workplace clinic. No other vaccine in four weeks. Patient is not pregnant. The patient previously took BNT162b2 (lot number: EL0140) first dose on 18Dec2020 12:00 PM (age 26-year-old) Intramuscular on left arm at single dose for covid-19 immunization and experienced Sore arm, joint pain that started in the left elbow and moved down to the wrist/hand and eventually joint pain and body aches all over for the next 2 days. For 2nd shot: Dizziness, nausea, fever, body aches, joint pain, throbbing headache x 24 hours. Started at 9pm on the evening of the shot (12Jan2021) and symptoms ceased exactly 24 hours later. The outcome of the events was recovered on 13Jan2021 21:00. No treatment for the events.

About 2 minutes after injection, I had a sudden rush of warmth throughout my body starting in my abdomen then causing my pulse to feel like it was pounding out of my neck. Got light headed. EMS came and my blood pressure raised to 155/95 and my pulse was up in the 150s and I was shaking. Started to go down but felt crappy for over 2 hours. Happened again 30seconds after the second injection. Pulse up to almost 160. 02 stats stayed normal. Post first injection had sore arm and lots of fatigue and brain fog. Following the second injection 12 hours post started having nausea, and diarrhea. Continued to have joint pain, muscle aches, headaches for days, and my lymph nodes swelled up and were extremely painful.

Patient became light-headed about 5 minutes after injection. Patient was given water to sip and cool rag for forehead. Patient became faint and nauseated about 15 minutes later and required to be laid on the floor with feet elevated. Several attempts were made to assist patient to sitting over the next hour. Patient was unable as she immediately became more light-headed and faint. Patient was evaluated by ER physician after not being able to rise for 1.5 hours. Patient was then transferred via lift assist and wheelchair for outpatient fluids.

Went to ED on 1/14/21. emailed caregiver for information. As far as what happened, I received my 2nd dose of Pfizer on Jan. 13th @ 05:15 at hospital and started feeling symptoms roughly six hours later, symptoms being nausea, chills, splitting headaches, muscle fatigue, feeling tired and joint pain. I had understood that these side effects were common and not to worry, however, the next day on Jan. 14th around 11:00am, I blacked out at home. Luckily, my partner had caught me before I feel to the ground, but he stated that my eyes had glazed over, my breathing was shallow, and I hardly had a pulse. He was getting ready to do chest compressions, but I had come out of whatever fog that had knocked me down and became responsive. Around 12:00 pm I had arrived at the ED where they had given me a bag on NS, Zofran for the nausea and Toradol for some inflammation management. I believe I discharged from the ED around 15:20.

26 y.o. female with a copper IUD who received second dose of Pfizer vaccine. Developed vomiting, myalgia, and fever next day. These symptoms resolved but then developed pink colored hematuria two days post vaccine, and was seen in clinic that day. Urine sample collected with 4-10 RBCs and moderate amount of blood found from lab. Last menses two weeks ago. She did have similar issues years ago, but past lab results were not available. Was referred to urology.

Lymphadenopathy on right side of body, lymph node pain, fatigue, nausea, muscle pain, joint pain, fever

Felt fine until 12 hours after 2nd dose - extreme nausea and vomiting, high fever, alternating chills and sweats for ~6 hours. 40 hours after dose, woke up and had several painful bumps on vulva and labia- small and white, slight redness around them. No history of STDs, more than a year since last sexual activity. Did some googling to figure out what it was and closely matched what was described/photos in this paper .Searched "aphthous ulcers vulva" to confirm using more photos, and determine treatment/if I needed a doctor, and came across a web site, which then led me to believe they bumps were related to the vaccine. Treated with over the counter hydrocortisone 1% every 12 hours for a total of 4 applications, and bumps are mostly painless and reduced in size.

Fever, chills: lasted about 24 hours fatigue slight nausea: lasted about 48 hours Treatment was rest and electrolyte drinks

Nausea; Fever; Chills; Body aches; Lethargy; Injection site inflammation and swelling; Injection site inflammation and swelling; This is a spontaneous report from a non-contactable healthcare professional reporting for self. This 26-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number=EL9261) on 20Jan2021 10:00 AM at single dose (vaccine location=left arm) for COVID-19 immunisation. Medical history was none. No known allergies. Concomitant medications were not reported. The patient previously received first dose of BNT162B2 (lot number=EL0140) on 30Dec2020 07:15 PM at single dose (vaccine location=left arm) for COVID-19 immunisation. The were no other vaccine in four weeks, patient did not have COVID prior vaccination. Patient was not pregnant. The patient experienced nausea, fever, chills, body aches, lethargy, injection site inflammation and swelling on 21Jan2021. No treatment received. Patient did not test COVID post vaccination. The outcome of events was recovered in Jan2021. No follow-up attempts are possible. No further information is expected.

1st dose vaccine 1/21/21; developed nausea, weakness, vomiting, diarrhea, and chills on 2/4/21; seen at ICC 2/5/21.

Severe chills, fevers up to 102 F for 24 hours after, nausea, one episode of emesis, fatigue, and body aches. These lasted for approximately 2 days following the vaccine. Mild cramping similar to menstrual cramping 2-3 days following initial symptoms, no bleeding. Mild teeth sensitivity for 2-3 days about the same time frame as uterine cramping.

Chills; heart racing; Vomiting; This is a spontaneous report from a contactable healthcare professional (patient). A 26-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number and expiry date: not known), via an unspecified route of administration in the left arm on 23Jan2021 15:15 at single dose for COVID-19 immunization. The patient's medical history was not reported. There were no concomitant medications. No known allergies. The patient is not pregnant. No other vaccine in four weeks and no other medications in two weeks. The patient had no COVID prior vaccination and not tested with COVID test post vaccination. The patient experienced chills, heart racing, and vomiting, 4 hours after vaccination on 23Jan2021 19:15. The outcome of the events was not recovered. Information on the lot/batch number has been requested.

After the first vaccine, I had a severe migraine for over 48 hours. I had to contact my neurologist for rescue medication. After the second dose, I had chills, sweats, body aches, migraines, nausea, and dizziness for 24 hours.

13 hours post vaccine: muscle body aches all over. About 16 hour mark: feverish, chills. Lasting throughout the night. Took 2 ibuprofen 200 mg 25 hours after. Vomited once.

Day 1: low grade fever, headache, abdominal pain. Went away with Ibuprofen. Day 2: severe abdominal pain; decreased with IV anti-inflammatory in hospital. Tests revealed colitis.

Syncope; Passed out within minutes of second dose.; Urination and emesis upon waking up; Urination and emesis upon waking up; This is a spontaneous report from a contactable Pharmacist (patient). A 26-year-old female patient not pregnant received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in Left arm (at age of 26-year-old) on 17Jan2021 at 09:30 AM as a single dose for COVID-19 immunisation, lot number: EL1283. Medical history was not provided. Patient had no known allergies. Patient received first vaccine dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 27Dec2020 at 09:30 AM via an unspecified route of administration in Left arm (at age of 26-year-old) for COVID-19 immunisation, lot number: EH9899. Patient did not receive any other medications within two weeks prior to the vaccination. Patient did not receive other vaccine in four weeks prior to the COVID vaccine. Prior to vaccination the patient was not diagnosed with COVID-19. On 17Jan2021 at 09:45 AM patient experienced syncope. Passed out within minutes of second dose. Urination and emesis upon waking up. Brought to hospital, given 1L nacl and 1 dose of ondansetron (ZOFRAN). Events considered serious due to hospitalization. Events resulted in Emergency room/ department or urgent care. Patient was treated with fluids and ondansetron (ZOFRAN). Patient was not tested for Covid post vaccination. Patient recovered from the events on unknown date.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a temporal relation. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.

COVID vaccine at approximately 0815 on 2/19/21. Thirty minutes after receiving the vaccine patient started experiencing nausea and dizziness. A few minutes after the nausea began she had one episode of vomiting. She was asked to sit at the Nurse's station and elevate her feet. Her BP was 123/79, HR 88. Patient was advised that she needs to go to the ED. At first she did not want to go to the ED. She was convinced of the need to go and one of the Ophthalmology staff members took her to the ED.

After receiving Pfizer Covid vaccine, patient developed symptoms of dizziness, nausea, a little shortness of breath. Reported she had a history of asthma and said she felt like "her limbs weren't working". She agreed to be taken to ED for evaluation. Was treated with fluids, ondansetron, and lorazepam IV push one time. Never treated for allergy/anaphylaxis.

It started 5-6 hours after the shot with headache and dizziness . In the evening I had a fever of 37,6°C and because I was scared it will be higher I took pills for fever. On the second day I had muscular pain and my fingers were swollen in the morning. Also I had lower back pain, runny nose and I was nauseous . On the 3rd day I was feeling dizzy, nauseous, couldn't concentrate and an intense headache. Pills weren't helping at all

That night my fever 102 took Tylenol to bring it down, shakes, chills , nausea, muscle aches and swollen lymph nodes (right armpit).The symptoms lasted to Sunday. My estimated date of delivery was Sept.14 I miscarried at 5 wks.

Fever on 2/27 AM (99.9F after ibuprofen was taken an hour before for headache; very mild chills/nausea/hot flashes; subsided later that night), Headache 2/26 PM and 2/27. I also had a headache on the day of the first vaccine dose from Pfizer (2/4/21; EM9809 dose in AM; headache in PM).

Slight pain at the injection site; muscle and joint aches (mostly in shoulders and back) which caused difficulty sleeping at night; muscle and joint aches (mostly in shoulders and back) which caused difficulty sleeping at night; muscle and joint aches (mostly in shoulders and back) which caused difficulty sleeping at night; Slight nausea; This is a spontaneous report from a non-contactable consumer (patient). A 26-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL3247), via an unspecified route of administration on 26Jan2021 at a single dose on the left arm for COVID-19 immunization. The patient's medical history was not reported. Concomitant medications included ethinylestradiol, norgestimate (ESTARYLLA), valacyclovir, cyanocobalamin (B12), iron, and colecalciferol (D3). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. On 26Jan2021, the patient experienced slight pain at the injection site, muscle and joint aches (mostly in shoulders and back) which caused difficulty sleeping at night, and slight nausea. The patient did not receive any treatment for the reported events. Since the vaccination, the patient has not been tested for COVID-19. The patient was not pregnant at the time of vaccination. The outcome of the events was not recovered. No follow-up attempts are possible. No further information is expected.

decreased appetite; Sweats; Chills; fever (101.3); headache; Body aches; This is a spontaneous report from a contactable Other-HCP (patient) and another other-HCP. This 26-year-old female received dose 2 of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Lot number EL0142, intramuscular in left arm on 11Jan2021 at 07:00 as single dose (at the age of 26 years) for Covid-19 Immunization. Relevant medical history was reported as none and concomitant medication was not reported. The patient had historical vaccine on 21Dec2020 at the age of 26 years of BNT162B2 for Covid-19 immunization and experienced Onset of body aches 12 hours after vaccination and lasted for 24 hours. (Lot Number/Expiry Date: EH9899, Route: intramuscular). The patient experienced Body aches, headache, fever, chills, sweats on 11Jan2021 18:00 and recovered on 13Jan2021. Patient received Tylenol extra strength 100mg on 11Jan2021 for symptoms. Patient experienced decrease appetite on unspecified date with outcome of unknown. The other HCP consider the Pfizer product had a causal effect to the adverse event.

Soreness and swelling at injection site (right arm); Soreness and swelling at injection site (right arm); Fatigue; Nausea; Headache; This is a spontaneous report from a contactable consumer (patient). This 26-year-old non-pregnant female consumer received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number EN5318) via unspecified route of administration in the right arm on 27Jan2021 at 11:00 (at the age of 26-years-old) as a single dose for COVID-19 immunization. Medical history was not reported. The patient did not have COVID-19 prior to vaccination, and did not receive any other vaccines in the 4 weeks prior to vaccination. Concomitant medications included paracetamol (TYLENOL) from an unknown date for an unknown indication; ibuprofen (ADVIL) from an unknown date for an unknown indication; and ethinylestradiol, etonogestrel (NUVARING) from an unknown date for an unknown indication. On 27Jan2021 at 21:00 the patient experienced soreness and swelling at injection site (right arm), fatigue, nausea, and headache, all lasting 24 hours after inoculation. No treatment was received for the events. The clinical outcomes of soreness and swelling at injection site (right arm), fatigue, nausea, headache, were recovered on 28Jan2021 at 21:00. It was also reported the patient did not test for COVID-19 post vaccination.

headache, body aches, injection site pain, GI upset and severe swelling of lymph nodes under my L arm (axillary region) at this time I have a golf ball sized lymph node in my L armpit that is tender to the touch

vertigo; light headedness; nausea; This is a spontaneous report received from a contactable other health professional (patient herself). A 26-year-old female patient (not pregnant) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via an unspecified route of administration on left arm on 19Jan2021 12:15 at single dose for COVID-19 immunisation at hospital. Medical history included depression and anxiety. The patient had no allergies to medications, food, or other products. Concomitant medication included trazodone at 100 mg and sertraline at 150 mg; both are received within two weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. It was reported that, two weeks after vaccine (on 01Feb2021 22:00) the patient had onset of vertigo, light headedness, and nausea. Patient still experiencing vertigo 12 hours later. Did not imbibe alcohol or substances. Did not do strenuous activity. The adverse events result in doctor or other healthcare professional office/clinic visit. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The events were assessed as non-serious by the reporter. The outcome of the events was reported as recovering. Information on the lot/batch number has been requested.

High blood pressure of 150/100; Arm swelling; Arm swelling/The swelling has gone down, but it is still swollen. It is still hurting.; Tenderness; Feeling faint/Felt dizzy; Some trouble breathing; disoriented; Fatigue; Chills; Nausea; This is a spontaneous report from a contactable consumer (patient) via Medical Information Team. A 26-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: EN5318), via an unspecified route of administration at left arm on 28Jan2021 at 16:55 (reported as 4:55 PM) at SINGLE DOSE for COVID-19 immunisation. It was given at a vaccination clinic. The patient had no prior vaccination within 4 weeks and had no adverse events following prior vaccinations and that was why she thought she would be fine. The patient had no additional vaccines administered on same date of bnt162b2. Medical history included anxiety, peanut allergy, tree nut allergy, and has had anaphylactic reaction in the past. Family history included her dad has heart disease and her half sister has heart disease. There were no concomitant medications. Historical vaccine included flu vaccine on an unspecified date for immunization. The patient stated, "You kind of feel yucky after the flu vaccine, but she has never had this with a flu shot." The patient stated that she hasn't had a flu shot in years. The patient asked if arm swelling was a normal occurrence after vaccination and if side effects can last for 4 days. The patient reported that she received the first dose of the COVID vaccine on 28Jan and afterwards experienced, arm swelling, and tenderness that has last for 4 days. She also reported experiencing feeling faint, high blood pressure of 150/100 and some trouble breathing on an unspecified date and nausea. The patient further reported that she was calling because she got her first dose of Pfizer's vaccine and she was curious if this was normal and if she needs to go see her doctor and she wants to report the symptoms. After she got the injection she felt super faint and got really high blood pressure on an unspecified date. She was not sure if it was because she had anxiety, but she had trouble breathing on an unspecified date. She got nauseated afterwards. Her arm swelled up really big and the swelling has stayed there for four days. Her arm was still swollen on an unspecified date. She has allergies and has had anaphylactic reaction in the past. She was still nauseated and feels super tired. The patient asked how long do the symptoms last. The patient's weight was reported between 122 to 123 pounds. The patient clarified that the nausea started 15 minutes after she got the shot on 28Jan2021. The nausea has lasted through this. She got chills the next day (29Jan2021) after the shot. She has felt super fatigue. The swelling has gone down, but it was still swollen. It was still hurting. She has no idea if that was normal. She also felt dizzy and disoriented after getting the shot. She was not sure if it was because her blood pressure was so high. It was high for her because her blood pressure was normally low. She thinks her blood pressure 150/100 after she got the vaccine. The outcome of all the events was unknown.

nausea; vomiting; chills; joint and muscle pain; joint and muscle pain; headache; fatigue; This is a spontaneous report from a contactable consumer (patient). A 26-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number and expiry date not reported) via an unspecified route of administration, at the age of 26-year-old, on an unspecified date, at SINGLE DOSE for COVID-19 immunization. The patient medical history was not reported. There were no concomitant medications. The patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) on an unspecified date, single dose for COVID-19 immunization. On an unspecified date, following administration of second COVID-19 vaccine, the patient experienced nausea and vomiting, chills, joint and muscle pain, headache, and fatigue. Onset of symptoms occurred approximately 5 hours after administration of medication and became progressively worse over the next 20-24 hours following administration of dose. Symptoms began to resolve around 26 hours post administration of medication. Outcome of the events was recovering at the time of the report. No follow-up attempts are possible. Information about batch number cannot be obtained.

Throat numbness, difficulty swallowing. Given Benadryl 25 mg PO. BP 136/85 (pulse 134), O2 sat 96%. F/u BP 127/92 (pulse 131), O2 sat 98%. MD rec'd ED, patient declined.

Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Mild, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Mild, Systemic: Tachycardia-Mild, Additional Details: patient is able to swallow and drink water .Just complained of sore throat,. Called 911 , assessed patient \"Anxiety Reaction\".\r\n

26 y.o. female who was seen at SVH COVID Vaccine Clinic today for her first dose of the COVID 19 vaccination. She was given the Pfizer vaccination in the left deltoid muscle. During her 15 minute waiting period after the injection, the patient began to experience headache and nausea. She denied rash, hives, welts, difficulty breathing, difficulty swallowing, wheezing, throat tightness, hoarseness, stridor, lightheadedness, dizziness, facial swelling, lip swelling and tongue swelling. This provider was notified of patient reaction and she was then assessed in the emergency bay area. Monitored patient for severe reaction symptoms, including but not limited to blood pressure abnormality , rapid progression of symptoms and vomiting. Past Medical History: Diagnosis Date ? Abnormal Papanicolaou smear of cervix with positive human papilloma virus (HPV) test 5/3/2017 ? Allergy seasonal ? Anxiety ? Asthma allergy induced ? Carpal tunnel syndrome ? Depression ? Head ache ? Herpes simplex vaginal ? Iron deficiency anemia in pg only ? PCOS (polycystic ovarian syndrome) ? Postpartum hemorrhage of vagina 12/29/2017 Hymenal laceration with small vaginal extension, heavy bleeding, resolved with repair. Uterine tone maintained. ALLERGY REVIEW OF SYSTEMS: Patient complains of headaches Patient denies chills, fever, malaise/fatigue, facial swelling, sore throat, frequent throat clearing, eyes itching, cough, chest tightness, shortness of breath, wheezing, rash, hives, eczema, itching of skin, vomiting, abdominal pain, muscle aches and joint pain + nausea: Previous Reactions: none Objective Vitals Vitals: 03/08/21 1054 03/08/21 1114 BP: 121/71 114/73 BP Location: Right arm Patient Position: Sitting Pulse: 74 69 SpO2: 100% 100% Physical Exam Constitutional: General: She is not in acute distress. Appearance: Normal appearance. She is well-developed. She is not diaphoretic. HENT: Mouth/Throat: Mouth: Mucous membranes are moist. Pharynx: Oropharynx is clear. Eyes: Extraocular Movements: Extraocular movements intact. Conjunctiva/sclera: Conjunctivae normal. Pupils: Pupils are equal, round, and reactive to light. Cardiovascular: Rate and Rhythm: Normal rate and regular rhythm. Pulses: Normal pulses. Heart sounds: Normal heart sounds. Pulmonary: Effort: Pulmonary effort is normal. No respiratory distress. Breath sounds: Normal breath sounds. No wheezing. Skin: General: Skin is warm and dry. Neurological: General: No focal deficit present. Mental Status: She is alert and oriented to person, place, and time. Gait: Gait normal. Psychiatric: Mood and Affect: Mood normal. Behavior: Behavior normal. Thought Content: Thought content normal. Judgment: Judgment normal. Assessment/Plan Treatment included: water and tylenol (500 mg), ibuprofen (200 mg) and pepcid (20 mg). she had already taken 600 mg of ibuprofen and 500 mg of tylenol this am for her dental work. Ice pack as well on neck Follow up response to treatment: good. Patient discharge: Stable to go home and follow up with PCP. Differential Diagnosis: Red flag symptoms (CP, SOB, NVD, Visual/Neuro concerns) Headache and nausea. Symptoms improving with medication treatments as listed above. Nausea resolved. She feels comfortable going home. She was monitored in the bay for 25 minutes. She denies any concerns. Follow up with pcp as needed.

Extreme soreness in left arm - to the point raising arm to remove clothing was difficult, migraine, sharp lower back pain, full body chills, feverish, loss of appetite, dizziness, full body fatigue.

Pain and swelling at injection site, muscle of injected arm is achy, hard to lift even to shoulder-height, itching at injection site, body aches, headache, upset stomach/nausea (but no vomiting or diarrhea)

Pt. has a history of dizziness/nausea after vaccination. 15 minutes after this vaccination, she had a short 'seizure-like' episode accompanied with slight shortness of breath. Pt. was also very dizzy and nauseous. Sweating came shortly after. EMS was called immediately when first symptoms began. She was responsive the entire time and reported gradually feeling better after about 5-10 minutes. EMS did a prompt check-up and revealed no unusual findings.

A week after my shot and I'm still having strange reactions. The day after the shot I started getting really bad cramps and other PMS symptoms like bloating and tenderness (even though I'm on a type of birth control that means I don't get a period). Then a few days later I started my period and has continued. I also have developed the kind of rash that I get when I eat wheat--all over my body and itchy and it hasn't gone done. Finally, it also caused a lot of digestive issues and bloating and gas. it makes me very nervous to get my next shot.

At around 10 hours after receiving the vaccine, i had noticeable side effects. The worst one was chills. I had sudden and severe chills for several hours. 2 hours later i developed a severe headache, mild nausea, and muscle aches. The next morning, i felt very tired and had moderate muscle aches all day long.

Patient reported about 5 minutes after vaccine at that she felt nauseous like she would throw up, checked bp 105/80 and Pulse 97, gave water and crackers, nausea resolved in about 10 minutes. at 11:35 checked bp 118/93 pulse 88. Patient didn't know what her normal bp and pulse are. FU call on 3/13 pt stated she only had coffee that morning, no food. she felt better after she left the store.

102F fever, headache and joint pains about 14 hours after the shot. Headache better on day 2 but fever continued until I took Tylenol. Started to feel nauseous starting Day 2.

Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Nausea-Severe, Systemic: Vomiting-Severe, Additional Details: Patient went to sit at observation area for 15 minutes.Observer noticed pt was pale and called over pharmacists.Patient was on the verge of passing out then vomited. We put cold compress on her neck and gave her water. Patient appeared better but then voseemed like she was going to pass out again. We called 911.EMT came, patient vomited again and seemed like she was going to pass out again. EMT took patient to ER. Patient was later discharged that night.

Developed a sore arm around 10pm, woke up with severe 7/10 body aches that quickly worsened leading to almost fainting, and sick to stomach along with mild headache.

Within two hours of my shot, I had a headache/muscle aches and felt dizzy/dissociated, and left work early. I started to feel feverish in the early evening, I began experiencing nausea around 3 am that night. This became vomiting about twenty minutes later. I vomited four times over the course of the next half hour: 3:30-4:00 am. I also started experiencing diarrhea at about 4:00 am. I had five loose, near-water stools over the course of the rest of the night until around 9 am, two of which I vomited at the same time. By the time the worst of it stopped, I'd vomited 10 times from 3:30 am - 10 am. I also experienced a fever from that afternoon onward, with chills/night sweats throughout the worst of the digestive upset until the morning. I couldn't keep fluids down until midmorning 3/18 and couldn't keep solids down until that evening, around 7 pm. It's 3/19 and I've had two glasses of water and a piece of toast and still feel nauseous. A friend of mine had some Zofran, which I took one dose of around 10 am 3/18, which allowed me to keep fluids down and not have to return to the hospital.

Pfizer-BioNTech COVID-19 Vaccine EUA Injection site pain tiredness headache stuffiness muscle pain, pain at base of head and top of neck, hip pain, knee pain chills fever (2 days at 100F) nausea dizziness itchiness

nausea - from 0400 2/4 until 1600 2/4 vomiting x1 episode 2/4 at 0830 myalgias, fatigue, fever and chills from 0400 2/4 until 2/6 pounding headache all day 2/4 and 2/5

I was 34 weeks at the time of vaccination. Initially, I only had pain at the injection site. I woke up the next day with diarrhea that lasted about 6 days. I had no other symptoms besides dehydration and back pain. On Day 3, I was instructed to take Imodium, which I took for about 2 days, but it didn't help. Around Day 5, I was given fluids, my urine was tested and multiple GI tests were run. I was placed on antibiotics for a UTI. PVCs were also discovered at visit, but it's not connected to the vaccine.

Pt developed dizziness and nausea approx 30 minutes after vaccination. Denies HA, SOB, chest pain. BP 131/84 HR 88 RR 18, unlabored SpO2 98% RA

Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Severe, Systemic: Allergic: Rash Generalized-Medium

Within two minutes of receiving the vaccination, she developed lightheadedness, sweating, and nausea. She was taken to a private section of the arena and monitored. Vitals were within normal limits. Her symptoms resolved after 10 minutes of monitoring.

1/15 vaccination Early afternoon, fatigue set in. That night i spiked fever over 100 and chills fever broke 1/16 pre syncopal episodes. Did pass out while sitting down. By noon, I had fever and chills, fatigue. broke that afternoon. By 7pm I got another fever, chills, and had abdominal pain with GERD. Was not due to food as hadn't ate. Couldn't speak due to the pain. No medication taken. Husband called PCM worried about hydration. Took Tylenol and kept fluid down. Big inflammatory response. Symptoms lasted for 48 hours

Approximately 7-9 minutes after receiving her first dose of the Pfizer Covid vaccine the patient began vomiting.

Stayed 30 minutes after vaccine at vaccination clinic to be safe in case of a reaction. About 5 minutes after leaving 11:30 I could taste the vaccine in my mouth. I immediately felt intense sharp tingling in my lower lip, it felt hot and swollen (upper lip never had a reaction). I instantly felt a lump in my throat and had a hard time swallowing. I started with chest pain that resolved itself in a minute or two. A few minutes later a family member noticed my face was red and flushed and said I looked like I had a sun burn. Swelling in throat resolved within an hour. Lip never visually looked swollen but I could feel the tightness, burning and tingling that resolved within the hour. Redness on face resolved within a couple hours. Had tiny blisters about 3 show up above upper lip I still have them the next day with a couple more but they aren't causing problems. My airway was never blocked I never had a hard time breathing. I did have a sore throat this morning March 25 day after vaccine. All other symptoms seem normal.

Time: 14-16 hours Severe body aches, chills, fever of 100.9, intense headache, nausea, dizziness, continuous sweating

Fever, chills, body aches, muscle and joint pain, nausea, vomiting, diarrhea, trouble concentrating , headache. These symptoms lasted about 30 hours. Headache, trouble concentrating, pain at injection site have lasted almost 48 hours and continue to exist but have been reduced over time

Patient reports feeling like she is going to vomit. Patient appears pale and sweaty. Placed patient into w/c and took her to private area. Patient is dry heaving. Gave patient a granola bar and apple juice at 1535. Within 5 minutes, patient reports feeling back to baseline. Patient's husband, escorted patient to car and will drive her home. Instructed to call PCP if symptoms worsen or new symptoms occur.

Client complained of feeling nauseous and dizzy after receiving 1st Pfizer Covid Vaccine(Lot# ER8734 Exp 3/31/21) at 1020. Client was walking out of restroom when she alerted EMT she was feeling dizzy and nauseous. Mother was present and had accompanied client to restroom. Per client could walk back to waiting room. Client was assisted by mother from restroom to walk to nearest chair. Fist assessment at 10:23: alert and oriented, blood pressure 130/100, pulse 83, oxygen 98. Per client no breakfast did morning and had not hydrated as well. Client given water and instructed to take small sips. Client denied headache, blurry vision, or vomiting in restroom. Client informed she would be observed for an additional 15 mins. Client asked if she could eat a snack as she felt she was feeling this way due to not having breakfast. Client advised to take small bites. Per client no history of allergies or reaction to vaccines and no current medication she takes. Within 5 minutes of sitting client stated symptoms were improving. Vitals at 1036: blood pressure 120/88, pulse 81, oxygen 98, alert and oriented. Client stated previous symptoms had resolved. Client advised to speak with provider prior to second dose. ER precautions given. Mother would drive client home. Client left facility at 1038 with a steady gait.

Crohn's flare - Feb 16th experienced abdominal bloating and distention, overnight Feb 17th vomited all night due to obstruction. Treated with oral steroids with no improvement, hospitalized March 17-21 for IV steroids with some improvement. Currently undergoing oral steroid taper, might need surgery.

Severe headache, sinus congestion, dizziness, nausea, diarrhea, heavy menstrual period, fatigue, drowsy, muscle pain, injection site soreness

Fainting; Fever of 103; Vomiting Green Fluid; Nausea; Body Aches; Shortness of breath; This is a spontaneous report from a contactable consumer (patient). A 26-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiration date unspecified), via an unspecified route of administration, administered in left arm on 03Apr2021 15:00 as single dose for COVID-19 immunisation. Medical history included psoriasis. The patient was not pregnant and had no known allergies. There were no concomitant medications. The patient received first dose of bnt162b2 on 13Mar2021, 14:30 for COVID-19 immunisation. On 04Apr2021 03:45, the patient experienced fainting, fever of 103, vomiting green fluid, nausea, body aches and shortness of breath that lasted 7 days after the second dose. There was no therapy for the events. There was no other vaccine in four weeks and no other medications in two weeks. The patient did not have Covid prior vaccination and was not covid tested post vaccination. Outcome of the events was recovered on an unspecified date. Information on the lot/batch number has been requested.; Sender's Comments: Based on temporal association, the causal relationship between bnt162b2 and the event syncope cannot be excluded. The information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.

I ended up starting my period April 20, 2020 (same day I got the vaccine) and it was the heaviest cycle I've had in years. I went through several tampons in a day for about a week til my period abruptly stopped on April 26, 2020. It started about 2 hours after the vaccination. I usually don't cramp but I was having problems sleeping because of how bad it got. I was also more bloated than my usual cycles. I dealt with extreme fatigue, I slept a lot that week and I did the bare minimum that week at work (which is unusual for me). I also don't usually have mood swings but I felt like my hormones were a bit intense to the point I kept snapping at people even though I like to think of myself as level-headed.

lost vision; migraine; unable to lift head; chest pain; nausea; This is a spontaneous report from a non-contactable consumer (patient). A 26-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date not reported), via an unspecified route of administration, administered at the right arm on 07Apr2021 10:45 (age at vaccination was 26 years) as single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was vaccinated at pharmacy or drugstore. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient had been tested for COVID-19. The patient experienced lost vision on 07Apr2021 with outcome of recovered on an unspecified date, migraine on 07Apr2021 with outcome of recovered on an unspecified date, was unable to lift head on 07Apr2021 with outcome of recovered on an unspecified date, chest pain on 07Apr2021 with outcome of recovered on an unspecified date, and nausea on 07Apr2021 with outcome of recovered on an unspecified date. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on an unspecified date. Therapeutic measures were taken as a result of lost vision, migraine, unable to lift head, chest pain, nausea that included migraine medication, ibuprofen, and nausea medication. No follow-up attempts are possible. Information about lot/batch number cannot be obtained. No further information is expected.

my arm slowly became more and more sore; had a hard time sleeping; woke up at 4am with full body aches (particularly felt like severe restless leg syndrome, but in my entire body); woke up at 4am with full body aches (particularly felt like severe restless leg syndrome, but in my entire body); stomach upset; fatigue; Little bit of chills; sluggishness; This is a spontaneous report from a contactable other hcp. A 26-years-old female patient (non pregnant) received bnt162b2 ((PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, Lot Number: Unknown) dose 1 via intramuscularly administered in left arm on 31Dec2020 10:00 AM and dose 2 via intramuscularly administered in left arm on 21Jan2021 12:00 PM (at 26-years-old and non pregnant at the time of vaccination )(Batch/Lot Number: EL3247) both as single dose for covid-19 immunization. Medical history included anxiety, asthma, allergies, irritable bowel syndrome from an unknown date and unknown if ongoing. No known allergies were reported. Concomitant medications included Sertraline HCL 100mg, Junel (birth control), Trazodone within two weeks. prior to vaccination. No other vaccine taken within four weeks prior to vaccination. Patient had no Covid prior to vaccination and not tested for Covid post vaccination. On 21Jan2021 at 05:30 PM, after second dose patient experienced sore arm slowly and became more and more. She had a hard time sleeping and woke up at 4am with full body aches (particularly felt like severe restless leg syndrome, but in her entire body). Also had stomach upset and fatigue/sluggishness. Little bit of chills. All of the symptoms continued throughout the rest of the day. Therapeutic measures taken which included Tylenol at 4am, 10am, and 4pm for it. Outcome of the event was recovered. Follow-up attempts are completed. No further information is expected.

Pt reports she has had an increased heart rate in the 110-120s for the past three days after receiving the COVID19 vaccination. Pt reports increased dizziness today, nausea, and in the past hour some chest tightness. Pt also reported recent travel to and from out of town, about 14 hours travel time in the past week and half. Pt given fluids, ruled out for illness and PE. Pt improved with fluids.

12/18/20- reports suddenly got sweaty, hands felt cold, then got nauseous. Reports vomitted x 1. Reports the rest of the day felt tachycardiac for a few hours (HR 120-140) and dizzy. Started getting muscle aches/joint aches. Denies any recent COVID exposure. Tested positive for COVID In 8/2020. Reports hips/knees are throbbing today; Heart rate WNL. /// Presenting today due to intermittent presyncope and palpitations. Also notes generalized weakness. Patient evaluate 2 L of fluid given her Mirena IUD D-dimer was sent which was negative patient with no pleuritic symptoms or dyspnea to suggest pulmonary embolism. Otherwise hemodynamically stable on exam ambulates with no difficulty no focal neurologic deficits. Patient did describe on her initial presentation that she noted some weakness of her bilateral legs. Given her possible viral reaction and description of weakness it is possible the patient is developing an early autoimmune reaction however she has no evidence of GuillainBarré or transverse myelitis on my exam. We will plan to discharge with neurology follow-up as outpatient.

Fever, chills, body aches, headache and abdominal pain. Took second dose yesterday, I was feeling fine and it all came back.

Saturday night headache took Tylenol, Sunday body aches chills headache dizzy nauseous weak, Monday vomiting headache dizzy heart palpitations body aches, Tuesday continued headache body aches

Sudden and continuous heartburn on 12/20/2020 which lasted all day. Took Lansoprazole on 12/20 and 12/21. Symptom resolved on 12/21.

Cervical lymphadenopathy; Chills; Nausea; Feeling lightheaded; This is a spontaneous report from a contactable physician (patient). A 27-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231/4130421), via an unspecified route of administration on 29Dec2020 10:00 in left arm at single dose for COVID-19 immunization. The patient's medical history was not reported. Concomitant medication included linaclotide (LINZESS) and a combination birth control pill both received within 2 weeks of vaccination. On 29Dec2020 at 10:00 PM (22:00), the patient experienced chills, nausea, feeling lightheaded and cervical lymphadenopathy. The symptoms were severe enough that the patient needed to leave work in the middle of her shift (primarily due to the lightheadedness). The patient tried drinking juice, water, etc but it kept getting worse so after a few hours the patient decided she needed to leave work. The patient did not received treatment for the events. The facility where the most recent COVID-19 vaccine was administered was in the hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was recovering. The event was considered non serious as it did not results in death, was not life threatening, did not cause/prolonged hospitalization, was not disabling/Incapacitating and had no congenital anomaly/birth defect.

Diarrhea; throwing up; very bad migraines; This is a spontaneous report from a contactable consumer (patient). A 27-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot number: EK5730, expiration date: Mar2021), via an unspecified route of administration on 27Dec2020 at single dose shot left arm once for COVID-19 immunization in hospital. The patient's medical history and concomitant medications reported as no. Patient stated that she got her Covid vaccine on Sunday (27Dec2020) and had experienced very bad migraines on 27Dec2020, diarrhea and throwing up as well on 29Dec2020. Stated that the diarrhea was not as common as the migraines. Stated that she had not thrown up but did last night (30Dec2020) at 2 AM. Investigation Assessment reported as no. No treatment was received for the events. The outcome of event migraines was unknown, outcome of the other events was recovering.

High fever between 102 and 106.1, chills, nausea and vomiting, headaches, and body aches. Treated with Tylenol and ibuprofen, fluids, and cool rags. Symptoms began 1/4/21 around 8pm with a fever of 102 that increased through the night to 104 after vomiting.

I experienced swelling in my face and lips, my chest became covered in hives. I was nauseated and felt like their was acid in my stomach (burning sensation). I had a headache. Was in the ED 12/31/20. Symptoms continue to happen at random.

I experienced swelling in my face and lips. Hives on my chest and neck. I went to the ED 12/31. I felt nauseated and there was a burning in my stomach. I had a headache. I have been experiencing these symptoms at random since the vaccine.

Unspecified general vertigo, general weakness, and occasional nausea starting from morning after vaccination that has been steadily improving day by day. Have tried meclizine OTC to no effect. Vertigo is mild and not impairing. Able to keep balance fine.

sore injection site the next day, next day at 10am began experiencing aches in my joints and achey muscles all over, mild headache, fatigue. At around 1pm experienced chills and fever. Experienced 3 episodes of diarrhea that started about 5 hours after the vaccine.

15 minutes after administration: began experiencing light headedness, nausea, and tightness in chest 1 hour after administration: began experiencing tightness in throat, irregular heart beat, and hypertension, anxiety/feeling of impending doom

Soreness from site of shot that radiated to most of my muscles and joints including shoulders, back, wrists, hips, and thighs. I also experienced nausea and a slight headache. I was unable to sleep because of my symptoms for at least 5 hours. I still am having some symptoms or aching as of 11:30am on 01/07/2021

10:51 metallic taste in mouth 10:58 tongue numbness, not able to feel tongue and on roof of mouth 11:08 hr 100-113 resp 20 bp 124/72 11:10 progressibly more difficulty when swallowing, lungs cta, individual was anxious 11:12 transferred to ED via wheelchair

Approximately 24 hours after receiving dose 1 of the Pfizer vaccine, I began having chills and vomited. My fatigue became more severe as well. Later that evening my fatigue persisted and I noticed a rapid heart rate via my Watch. My resting heart rate which usually is about 80 BPM was at 100 while laying down and not engaged in any physical activity. When I stood I was dizzy and had poor balance. While my entire arm no longer hurt, the injection site showed a bump as well. When I awoke the next day my heart rate appeared normal again, and I wasn't especially fatigued compared to before I got the vaccine. I did experience another minor gastro-intestinal episode later that afternoon, but otherwise my symptoms appeared to have passed aside from the fatigue. By the end of my work day I was very tired again, although it is uncertain if this is due to the vaccine or from my continued recovery from Covid and adjusting to the physical demands of going back to my job in-person. Because I received my vaccine on the same day as my first day back to work, I have no experience working post-covid before having the vaccine to compare my current state of fatigue to. On the evening of 01/07 I noted that fatigue was slightly less pronounced. I do not currently have a primary care doctor but will be calling to try to gain an appointment so that my second dose can be monitored.

Fever started on 1/7 at around 7:00am, highest was 100.2, Took tylenol Nausea, headache, body aches as well

Got 1st shot at 1430 1/4/21. Was sent back to my unit (OR). At 1455 got full body flush followed by tingling lips, tight throat, trouble swallowing and SOB. No obvious signs of swelling of the lips. Used inhaler for SOB which helped marginally. After 1.5 hrs tingling in lips and flushed skin went away. Throat tightness and SOB still remained but weren't progressing so went home after my shift. Later that night around 2100 took 1 25mg Benadryl. Tightness in throat and SOB improved. The next morning 1/5/21, I reported to work for my shift. Tightness and SOB was manageable at this point. At 0800 the tightness in my throat, trouble swallowing and SOB got significantly worse. I was scrubbed into a surgery and had to call for a replacement so I could take Benadryl. I took 1 25mg tablet and 2 puffs of my inhaler and went back to my case. After the Benadryl and inhaler, the tightness in my throat and SOB became slightly more manageable. At 1240 the symptoms came back and I took another Benadryl and 2 puffs of my inhaler with slight relief of symptoms. Stayed the rest of my shift continuing my inhaler as needed and a Benadryl every 4 hrs. At 1600 I developed a headache at the front of my head above my eyes like a weight was sitting there. The next day when I woke up 1/6/21, the tightness in my throat, SOB and headache were worse so I had to call into work. The headache that morning had progressed to 7 out of 10 pain and the pain then included my neck where it attaches to the skull. At 0830 I called employee health and they advised my to go to an urgent care. I was checked over by a PA and was prescribed prednisone 40 mg for 5 days along with Benadryl every 4 hrs and inhaler as needed. I was also nasal swabbed for Covid. After taking the steroid, the headache and neck pain, tightness in throat went away. The SOB also improved. Currently taking the steroid, Benadryl (every 4 hrs) and inhaler 2 puffs as needed. Symptoms are mostly controlled. 1/7/21 tried to cut back the Benadryl to every 6 hrs. Noticed a huge difference in my breathing and had an increase in SOB so went back to every 4 hrs. 1/8/21 still taking steroid and Benadryl every 4 hrs and inhaler. SOB is worse today even with taking Benadryl. Have an appointment with my PCP to talk about getting the 2nd shot.

I received high temperature of a 100.1; Muscle aches; muscle pain; Body aches; nausea; I was developing soreness at the injection site of the arm; This is a spontaneous report from a contactable consumer (patient). A 27-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EH9899; expiry date: unknown) via an unspecified route of administration, on 31Dec2020 at 12:20, at a single dose, as preventive measure for COVID. The patient has no relevant medical history. There were no concomitant medications. The patient received the vaccine on 31Dec2020 about 12:20. On the same day, midafternoon, patient developed soreness at the injection site of the arm. The following day (01Jan2021), in the morning, she had a high temperature of a 100.1 along with some muscle aches/ muscle pain, body aches, and nausea. Outcome of the events was unknown.

Tiredness, headache, chills, nausea, and feeling unwell.; Tiredness, headache, chills, nausea, and feeling unwell.; Tiredness, headache, chills, nausea, and feeling unwell.; Tiredness, headache, chills, nausea, and feeling unwell.; Tiredness, headache, chills, nausea, and feeling unwell.; This is a spontaneous report from a contactable other healthcare professional, the patient. A 27-year old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: unknown), via intramuscular route of administration in the right arm on 30Dec2020 at 12:30 PM (at the age of 27 years-old) as a single dose for COVID-19 vaccination. There was no relevant medical history. The patient did not have any allergies to medications, food, or other products. The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient's concomitant medications were not reported. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. On 31Dec2020, the patient experienced tiredness, headache, chills, nausea, and feeling unwell. The report was reported as non-serious. The patient was not treated for tiredness, headache, chills, nausea, and feeling unwell. The clinical outcome of tiredness, headache, chills, nausea, and feeling unwell was recovered. It was also reported that since the vaccination, the patient had not been tested for COVID-19. No follow-up attempts are Possible; Information about batch number cannot be obtained. No further information is expected

Headache, nausea, diarrhea, hot flashes, mild fever, loss of concentration/focus, fatigue, muscle aches. 12/23-1/9 (present) 2 virtual dr visits, recommended Tylenol and rest

Nausea, vomiting, diarrhea, fever, chills, dizziness, headache, muscle and joint aches, pain at the injection site, dry mouth, shortness of breath. Took ibuprofen and Tylenol.

I woke up in the middle of the night with chills, body aches, nausea, and over all weakness. I ended up throwing up. I only got 4 hours of sleep.

Vaccine: 12/30/2020 0900 AM Symptoms started: 12/30/2020 0925 AM Symptoms: tachycardia 150s, weakness, feeling extremely hot, lip and facial numbness, tightness on throat, difficulty swallowing, shortness of breath Duration: 1 hour Frequency post vaccination: QDAY but less severe ED Visit: 12/31/2020 prescribed Zyrtec and Pepcid Symptoms still occurring going on week two post vaccination

she left a message that she had a second vaccine on Jan. 7 and on 1/8 was very sick with chills, headache, shaky, and vomiting. She reports 1/9 that it is now gone (lasted about 24 hours).

At 2am that next morning January 8th (almost 12 hours post vaccine) I woke up out of my sleep delirious, light headed, heart was racing, diarrhea, and felt like I was falling in and out of almost passing out, hot flashes, couldn't think straight. It wasa very scary experience for me. This lasted about 15 or 20 minutes I'm guessing (hard to say for sure because I was too worked up to watch the clock) but I ended up making myself fall back asleep. The next day January 8th I had diarrhea multiple times in theafternoon and felt strange, somewhat lightheaded and some what felt like anxiety.

Myalgias, arthalgias, and headache starting at 12 hours after vaccine. These lasted 24 hours. Fever, chills, and nausea starting at 22 hours after vaccine and lasted for 14 hours. L axilla lymphadenopathy starting 38 hours after vaccine. Treatment was tylenol and ibuprofen prn.

1/11 10:30pm-severe headache and jaw ache/stiff jaw 1/12 AM-headache and jaw ache continues, nausea 1/12 afternoon-headache and jaw ache continues, nausea, low grade fever (99.9) and chills 1/12 night-headache and jaw ache 1/13 AM and afternoon-headache and jaw ache

Fever, chills, headache, body aches 12hrs after vaccine administration. Diarrhea 18hrs after administration. Symptoms lasted 24hrs.

Fever; body aches; joint pain; headache; diarrhea; dizzy spells; uncontrollable shakes; chills; This is a spontaneous report from a Non-contactable Other Health Professional (patient). A 27-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in left arm on 06Jan2021 13:45 at single dose for COVID-19 immunization. Medical history reported as none. Known allergies: NO (Allergies to medications, food, or other products: No). The patient's concomitant medications were not reported. List of any other medications the patient received within 2 weeks of vaccination: No. The patient experienced Fever, body aches, joint pain, headache, diarrhea, dizzy spells, uncontrollable shakes, chills, all on 06Jan2021 21:00 with outcome of recovering. Pregnant at the time of vaccination: No. Facility where the most recent COVID-19 vaccine was administered: Hospital. If the patient received any other vaccines within 4 weeks prior to the COVID vaccine: No. No treatment received for the adverse event. Prior to vaccination, was the patient diagnosed with COVID-19: No. Since the vaccination, has the patient been tested for COVID-19: Yes. Covid test post vaccination: Nasal Swab on 07Dec2021 with result negative. AE was not resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Serious: No. Seriousness criteria-Results in death: No. Seriousness criteria-Life threatening: No. Seriousness criteria-Caused/prolonged hospitalization: No. Seriousness criteria-Disabling/Incapacitating: No. Seriousness criteria-Congenital anomaly/birth defect: No. No follow-up attempts are possible. Information about lot/batch number could not be requested. No further information is expected.

Immediately after I got it I started feeling flush and hot in my face, I got dizzy and lightheaded, my HR went to 180, my legs felt weak, I was having chest palpitations and chest pain. I felt really dizzy and nauseated, I felt like I could not walk. I felt like I hit by a bus. The next day I had heavy flu symptoms, high fever, continuous chest pain and high HR, at the ER they gave me a high dose of Benadryl, steroids and fluids. I took Benadryl for about 7 days and I still felt light headed palpitations and fever for almost 2 weeks. I also was tested for COVID and it was negative. I was advised to not take the second vaccine. I still have a really bad fatigue. It is the symptom that is still on and off.

Instant headache. Dizziness 2 hours after injection. N/V/D, fever of 100.6, fatigue; Instant headache. Dizziness 2 hours after injection. N/V/D, fever of 100.6, fatigue; Instant headache. Dizziness 2 hours after injection. N/V/D, fever of 100.6, fatigue; Instant headache. Dizziness 2 hours after injection. N/V/D, fever of 100.6, fatigue; Instant headache. Dizziness 2 hours after injection. N/V/D, fever of 100.6, fatigue; Instant headache. Dizziness 2 hours after injection. N/V/D, fever of 100.6, fatigue; Instant headache. Dizziness 2 hours after injection. N/V/D, fever of 100.6, fatigue; This is a spontaneous report from a contactable health care professional. A 27-years-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), lot number= EH9899, intramuscular, in left arm on 15Dec2020 at 18:45 (at the age of 27 years-old), as a single dose for COVID-19 immunization. The patient received the vaccination at a hospital. There was no medical history and concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. It was not reported if the patient took any other medications in the 2 weeks prior to the vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. On 15Dec2020, the patient experienced an instant headache, dizziness 2 hours after the injection, nausea/vomiting/diarrhea (N/V/D), fatigue, and a fever of 100.6. The patient was not hospitalized for the reported events and no treatment was given. The clinical outcome of the events of instant headache, dizziness 2 hours after the injection, nausea/vomiting/diarrhea, fatigue, and a fever of 100.6 was recovered on an unspecified date. Since the vaccination, the patient has not been tested for COVID-19.

Fever, chills, nausea, light sensitivity, sound sensitivity, headache, dizziness, cold sweats, dry mouth all lasting over 36 hours.

Fever, sore throat, chills, congestion, cough, nausea, muscle aches, tachycardia. Treatment: Tylenol with no improvement Outcome: referred for COVID testing

Headaches, heart palpitations, dizziness, fatigue, weakness, lightheaded, and seeing dark spots (date/time of onset symptoms 1/13/2021 at 3:00PM) Headaches, heart palpitations, dizziness, fatigue, weakness, lightheaded, swollen lymph nodes, and hard to swallow ( date/time of onset symptoms 1/13/2021 at 4pm and still ongoing).

I received my 2nd shot 1/12 @3:30pm. 1/13 @5:00 I started having severe stomach cramps, a migraine, and vomiting that is still occurring 1/14 @ 8:10 am.

My injection was at 4:08 pm on 1/13/21. I woke up from a dead sleep at 2:30am on 1/14/21 and started vomiting for about 20-25 minutes. Also muscle pain at injection site.

Onset 12 hours after injection of alternating fever and chills, nausea, vomiting, myalgias, arthralgia, and headache.

Sudden severe arm and shoulder pain (left side) along with severe neck pain. I was unable to move my neck for about an hour. As well as left sided facial pain. Worst migraine of my life. Right leg/foot spasms. Heart palpitations, difficulty catching breath, Following day-moderate neck pain, headache, and very sore left arm, nausea, left shoulder pain

The morning after getting the 2nd COVID-19 vaccination, I walked to work and started to feel more fatigued than usual within about 40 minutes after starting to walk from my apartment at 0600. I had a hard time staying awake, started to become flushed and feeling feverish at 0700 at work, and began to develop a headache and nausea around 0745. I went to sick call on my ship after realizing I couldn't power through the symptoms around 0800, and my Senior Chief mentioned earlier in the report) sent me home with motrin, tylenol, and mucinex for any congestion that may come up. Today (14JAN21) I seem to be a little more active and have an easier time staying awake, the headache and nausea have dissipated completely. However, I am still feeling more fatigued than I have been lately, and I began to feel flushed and feverish again around the same time in the morning.

A series of several bumps have turned into sores inside of her mouth/ located on the right side of mouth inside the gum of her back bottom teeth and now turning into clusters of blisters; A series of several bumps have turned into sores inside of her mouth/ located on the right side of mouth inside the gum of her back bottom teeth and now turning into clusters of blisters; This is a spontaneous report from a contactable other healthcare professional (patient). A 27-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: EJ1686), via an unspecified route of administration in left arm on 31Dec2020 at 02:45 PM at a single dose for Covid-19 immunization. Medical history included Covid-19. Prior to vaccination, patient was diagnosed with COVID-19. Patient was not pregnant at the time of vaccination. Patient has no allergies to medications, food, or other products. The patient's concomitant medications were not reported. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 05Jan2021 at 05:45 PM, the patient experienced series of several bumps have turned into sores inside of her mouth. They are located on the right side of her mouth inside the gum of her back bottom teeth. They are now turning into clusters of blisters. It was unknown whether treatment was received for the adverse events. Since the vaccination, patient has not been tested for COVID-19. The outcome of the events was not recovered.

Body aches, chills, headache, nausea - emesis x1; Body aches, chills, headache, nausea - emesis x1; Body aches, chills, headache, nausea - emesis x1; Body aches, chills, headache, nausea - emesis x1; Body aches, chills, headache, nausea - emesis x1; This is a spontaneous report from a contactable nurse. A 27-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date not reported), via an unspecified route of administration on 07Jan2021 14:00 at a single dose on left arm for COVID-19 immunization. The patient's medical history was not reported. No known allergies. Concomitant medication included drospirenone, ethinylestradiol (YASMIN) for birth control. The patient previously received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date not reported), via an unspecified route of administration on 21Dec2020 08:00 at a single dose on left arm for COVID-19 immunization. The patient experienced body aches, chills, headache, nausea - emesis x1 on 08Jan2021 02:00. No treatment received for adverse event. The outcome of the events was recovering. The events were assessed as non-serious. Facility type vaccine was Hospital. No other vaccine received in four weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Information on the lot/batch number has been requested.

Patient presented to emergency department with nausea, diarrhea, fatigue, and body aches. Patient was given phenergan with resolution of symptoms. Patient was discharged home in stable condition

Patient received COVID 19 vaccine on 1/14/21 at approx 1428 without any complications. Patient was escorted to observation holding area for 15 minute observation post injection. Patient held from 1430-1445 without any difficulties experienced by patient. Patient speaking frequently during observation period with another stakeholder. Patient left at 1445 after observation was complete. Patient returned at 1500 stating her throat felt strange and she was having difficulty swallowing water. Patient escorted to bay for monitoring. Vital signs BP 150/101, HR 70, O2 sat 99% on room air. Per physician order patient given 50 mg Benadryl PO and 10 mg Zyrtec PO. Vital signs at 1509 were BP 148/87, HR 72, RR not documented, pt breathing on room air. Pt held and monitored. At 1610, pt stated "I feel something in my throat". Pt has no difficulty swallowing water. 1610 vital signs BP 138/92, HR 70, O2 Sat not recorded, breathing on room air.

chills, headache, fatigue, generalized aches, intermittent nausea (no emesis) -all symptoms lasting around 24 hours at this time

Around 6:00pm I started getting very severe upper abdominal cramps, and a headache. I was unable to do anything except lay down. Its currently 12:12am and I still have both symptoms.

Awoke with chills and very hot. Walked to bathroom to take Advil. Took 600mg Advil became nauseous and dizzy, sat down and became more dizzy and had loss of vision. Then laid down and a very moments later was able to sit back up. Was very sweaty and with tinnitus which lasted about 10 minutes and then Resolved itself.

When I went to get the shot, I had a firm bump with what looked like a white head on my left arm from the first shot. When she injected the 2nd dose, the bump was painful and grew twice in size on my arm and started bleeding. The technician rubbed the area for a fews minutes and the swelling went down. The bump went down, but the whole day, I felt a little sick. At around 7pm, I felt feverish, with muscle aches and chills. My skin was sensitive to touch, I felt nauseous, and I could barely walk. The bottom of my left eyelid also became a little swollen. The symptoms resolved the next morning.

Dizziness/light-headed, difficulty speaking, difficulty swallowing, mild tongue and throat swelling, constant need to clear throat, tingle/tickle in throat

Severe headache from 12-36h post administration impairing ability to perform ADLs with inability to turn head from side to side or to change positions without lancing temporal pain and a/w photophobia; Severe headache from 12-36h post administration impairing ability to perform ADLs with inability to turn head from side to side or to change positions without lancing temporal pain and a/w photophobia; Severe malaise; Severe headache from 12-36h post administration impairing ability to perform ADLs with inability to turn head from side to side or to change positions without lancing temporal pain and a/w photophobia; loss of appetite; Transient dysgeusia; Mild nausea; Pleuritic chest pain; This is a spontaneous report from a non-contactable physician. This 27-year-old female physician (patient) reported that she received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number=E15249), via unspecified route at left arm on 08Jan2021 07:30 AM at single dose for COVID-19 immunization. Medical history was none. Concomitant medication was not reported. The historical vaccine included the first dose of BNT162B2 for COVID-19 immunization. Facility type of vaccine was hospital. No other vaccine in four weeks. No Covid prior vaccination. No covid tested post vaccination. On 08Jan2021 06:00 PM, patient experienced severe headache from 12-36h post administration (as reported), impairing ability to perform ADLs with inability to turn head from side to side or to change positions without lancing temporal pain and a/w photophobia (nearly meningeal signs); mild nausea; pleuritic chest pain; severe malaise; transient dysgeusia; loss of appetite. Treatment for events included initially NSAIDs until had difficulty tolerating was received. Outcome of events was recovering. No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the time association, the possible contribution of suspect BNT162B2 to the events cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.

injection site was swollen; headache; chills; nausea; arm was sore for a few days; muscle pain; weakness; fever; This is a spontaneous report from a contactable nurse. A 27-year-old female patient received receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), Lot number: EH9899, intramuscular, in the left arm from 16Dec2020 17:45 at SINGLE DOSE for COVID-19 immunization. Medical history included asthma, Hypothyroid, HSV (Herpes simplex virus) and Penicillin allergy. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient hasn't been tested for COVID-19. Patient was not pregnant. Concomitant medication included levothyroxine sodium (SYNTHROID), cetirizine hydrochloride (ZYRTEC), and fluticasone furoate, vilanterol trifenatate (BREO ELLIPTA). On 17Dec2020 10:00, it was reported that the injection site was swollen for about a week. Her arm was sore for a few days and had muscle pain and weakness which also started on 17Dec2020 at 10:00. She also had headache, fever, chills, and nausea 17Dec2020 10:00. The outcome of events was reported as recovered. No treatment was received/ required due to events. No follow-up attempts possible. No further information expected. Information on the batch/lot number has been obtained.

Severe pain in temples and jaw, pain at hips, nausea and vomiting, low-grade fever (highest was 100.1 degrees F), dizziness.

After having vaccine, had flu like symptoms. These worsened into dizziness, vertigo, nausea, cough, and tilgling/palpatations. Describes brain fog and disorientation/vertigo that persists until today - day of reporting.

Fever (103 lasting a day and a half); Nausea; Chills; Muscle aches and soreness; Malaise; Lymphadenopathy; Arm/under arm/pec soreness in vaccine arm; Fatigue; Sore throat; Dry cough; recevied first dose on 21Dec2020 10:15, then received second dose on 07Jan2021 07:45; recevied first dose on 21Dec2020 10:15, then received second dose on 07Jan2021 07:45; This is a spontaneous report from a contactable nurse (patient). A 27-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number not reported), via intramuscular on 07Jan2021 07:45 at single dose in left arm for covid-19 immunization. The patient had no medical history and no known allergies. Concomitant medication in two weeks included birth control. The patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number not reported), via intramuscular on 21Dec2020 10:15 at single dose in left arm for covid-19 immunization. The patient had no other vaccine in four weeks. No covid tested post vaccination. The patient experienced fever (103 lasting a day and a half), nausea, chills, muscle aches and soreness, malaise, lymphadenopathy and soreness, arm/under arm/pec soreness in vaccine arm, fatigue, sore throat, dry cough on 07Jan2021 19:00. The patient did not receive any treatment for these events. The outcome of the events fever (103 lasting a day and a half), nausea, chills, muscle aches and soreness, malaise, lymphadenopathy and soreness, arm/under arm/pec soreness in vaccine arm, fatigue, sore throat, dry cough was recovered in Jan2021. Information on the lot/batch number has been requested.

Fever; Chills; Total body aching; Nausea; Headache; Tiredness; This is a spontaneous report from a contactable nurse (patient). A 27-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0142), via an unspecified route of administration (left arm) on 08Jan2021 (07:45) at single dose for Covid-19 immunization. Medical history included kidney reflux as child, gallbladder removal at 18, and known allergies: rubber allergies, lactose intolerant, and seasonal allergies. Concomitant medications included ascorbic acid (VITAMIN C) and Multivitamins (ritual women 2 a day). The patient previously received the first dose of BNT162B2 (lot number: EK5730) on 18Dec2020 (06:00 AM) via an unspecified route (left arm) for Covid-19 immunization. The patient was not diagnosed with COVID-19 prior to vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 08Jan2021 (21:00), patient experienced chills, total body aching, nausea, headache, tiredness; and fever for about 24 hours starting about 18 hours after received the vaccine on 09Jan2021 (01:45). It was reported that it was hard to keep the fever down with just Tylenol, the patient needed to take ibuprofen. There was no treatment received for the other adverse event. The outcome of events was recovered with lasting effects (unspecified date). The patient has not been tested for COVID-19 since the vaccination.

First started off with a cold feeling around injection site. Around 11:30 at night I felt muscle aches in my calves. 30 minutes later my legs were having severe muscle aches and joint pain in my ankles. I was having cold chills and aches the whole night along with sweating. On 1/20/2021 (the next day) the muscle aches, chills, and joint pain continued through the whole day. I was nauseous at times and did not have an appetite. Around 5 o clock I felt some relief with my leg pain but it started again around 9 o clock. I continued switching Tylenol extra strength and ibuprofen. I went to bed on 1/20 at midnight with little leg pain but major neck and back aches. I did not have cold chills through the night or sweating. Today (1/21/2021) leg pain is near gone, but joint pain is still there in my left ankle and knee. My legs feel heavy and strange and is causing me to walk slowly because I feel like my legs are very fatigued and off balance. I have had neck and back aches all day. I have not had chills today

Sore arm right after shot and throughout the next day. Woke up in the middle of the night (around 11:45pm)with very bad chills, nausea, and headache. Temperature at the time was 99.7. Several hours later (around 3:45am) woke up again with less chills and temperature 101.6-101.8 with headache continuing. Woke up again at 5:45am with continued fever 101.7 and headache. Took ibuprofen around 6:30am and fever dissipated around 9am. Headache still continuing but not as severe.

3AM 1/13 WOKE UP WITH FEVER 12PM 1/13 VOMIT. ALL DAY FEVER, MUSCLE PAIN TOOK TYLENOL 1 GRAM @ 4AM 1/13 12PM 1/13, 10PM 1/13

Dizziness and blacked out. Followed by severe nausea/vomiting. Went to local ER that evening for further symptom treatment.

Pt received dose#2 and c/o allergic reaction with faster onset. Pt reported dizziness/neck stiffness and right sided headache, nausea. States feels weak on the right side but no numbness. No slurred speech. No facial asymmetry. Pt denies any SOB/throat tightening. Dizziness less severe this time per patient. She was dizziness for 3 days with dose #1. Patient was discharged at 2112.

tested positive for covid; tested positive for covid; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (patients mother) reported for a 27-year-old female patient received her first dose of bnt162b2 (BNT162B2 also reported as PFIZER-BIONTECH COVID-19 VACCINE, lot EJ1685), via an unspecified route of administration in the left arm on 17Dec2020 at single dose, for Covid-19 immunisation. Medical history included was sick 4-5 days in Feb2020 or Mar2020. There were no concomitant medications. After the 1st dose, the patient had fatigue after the 3rd day. After a week she felt like she had loose motions in other words diarrhea. She lost her smell and taste both (thought it was 27Dec2020). She got herself tested and it was positive. She tested positive on 28Dec2020. The outcome of event was unknown.

12 hours after the vaccination, I had fever, chills, headache, myalgias, dry cough, nausea, decreased appetite, nasal congestion.

Had itching at site immediately rash above site developed later in the day. About 10 minutes after injection developed nausea then felt very hot became clammy and sweaty. Felt lightheaded became pale had to played down on the ground.

Nausea (2-3 days) Constant headache Swelling in injection site Redness at injection site Feeling unwell

SEVERE shortness of breath (basically hyperventilating) for 2-3 hours, very sharp pains/heartburn in the chest when trying to take a deep breath, nausea, vomiting, diarrhea, joint pain, fatigue, chills/hot flashes, sudden uncontrollable fatigue (deep sleep for 2-3 hours after)

within minutes after my shot, I started to have difficulty swallowing. i was monitored for 30 minutes at the vaccine site before being escorted to the medical observation area. While in the medical observation area I tried to take a sip of water but could not swallow it. At that moment I began having a tight feeling in my chest. I began to hyperventilate followed by difficulty breathing or talking. This was accompanied by feelings of impending doom, and uncontrollable trembling and inability to concentrate on what the medical observation area Doctor was saying. The time from the drink of water until I was able to breathe, speak, and concentrate normally was about 20 minutes. Tightness in my chest has improved but not fully recovered. General malaise and headache have developed.

Nausea; I had a fever of 100.6; I feel like I still have a fever; Chills; This is a spontaneous report from a contactable consumer (patient). A 27-year-old female patient received first dose of bnt162b2 (Batch/lot number: EL1283, expiry date: 30Apr2021), via an unspecified route of administration on 10Jan2021 05:00 at single dose for covid-19 immunization. The patient had no relevant medical history and concomitant medications. The patient experienced nausea; had a fever of 100.6; feel like still have a fever, chills in Jan2021. The patient had been experiencing like nausea and I had a fever earlier like around 5:00 in the morning and I got my vaccine on 10Jan2021, the first dose. In the morning like around 5:00 am, she had a fever of 100.6. she felt like she still had a fever and she took paracetamol (TYLENOL) (later clarified that consumer took paracetamol as treatment) around 5:00 in the morning and then she took it again at noon. she still felt the fever and like she felt chills and the nausea. The second dose was going to be on 31Jan2021. She took paracetamol 500 mg in morning and 500 mg in afternoon for fever and nausea as a treatment. The patient underwent lab tests and procedures which included body temperature: 100.6 in Jan2021. The outcome of events was not resolved.

Reaction from second covid vaccination; worst reaction being diarrhea, which was around 2100 on 1/22/21

Profuse vomiting and severe epigastric pain starting 14 hours after receiving vaccine. Unresolved 24 hours after receiving the vaccine. Also felt very nauseous and had severe epigastric pain after receiving first dose of Pfizer vaccine but did not vomit.

Injection sight and left arm pain started immediately. Nausea started around 10:20am, increasing as time passed, started hot flashes , cold flashes and shakes around 11am, right kidney (?) area on back started to hurt around 11:30am pain increasing as well. All persistent until about 5:30pm where the kidney (?) pain subdued followed by the hot and cold flashes around 7pm. Nausea and shakes passed by 1/30/21 am after I woke up. Full Left arm pain continued all day 1/30/21.

1/27 , 13 hours after vaccination (dose #2), 2:30am- strong rigors. Temp 102 1/27-1/28 SEVERE pain on the top and back of head, neck pain, and back pain. Pain untouched by consistent 1000mg tylenol and 600mg iburpofen. Also, generalized joint and muscle pain + weakness. I was unable to sit up these days. 1/27-1/29 Fevers for 3 days straight. Unable to get temperature below 99.8 even with Tylenol. Alternated 600mg Ibuprofen and 1000mg Tylenol. 1/28-1/29 Diarrhea - 5-6 bowel movements

Headache right after vaccine was administered. Approximately 40min after vaccine was administered I had severe dry mouth, inability to swallow, at about an hour after vaccine was administered my lips tongue and throat were swelling. Diarrhea, chills, dizziness, severe tremors.

Patient sitting in chair of observation area. Suddenly felt dizzy. Observation staff RN brought patient to triage. Patient states she felt dizzy. Lightheaded, nauseated, started vomiting, vomited two times. Slightly diaphoretic. She is warm and dry BP elevated. Patient started to scratch back, lower and mid back. noted with scattered raised red rash. Patient drowsy and altered mental state gave Benadryl. Patient to triage cot, cold pack applied V.S and N.S. measured. Charge nurse present. Benadryl 50mg IM given per protocol. EMS activated. report given to paramedic crew. No further vomiting. V.S.S. SR on monitor O2 sat 99%. Remains orientated to name, place and date. Cannot open her phone or recall family emergency number. Patient sent to hospital with EMS.

Arm soreness, Emesis, Nausea, Urge to vomit for 24 hours, Insomnia, Lethargy, Body aches, Diarrhea

Diarrhea; Chills; Fever of 101.8; muscle pain; This is a spontaneous report from a non-contactable nurse (patient). A 27-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: El1283), intramuscular on 18Jan2021 00:45 at a single dose for COVID-19 immunisation. The patient's medical history included endometriosis and sulfa antibiotics allergy. Concomitant medications were not reported. The patient previously took the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) on 29Dec2020 at the age of 27 years old for COVID-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination and had not been tested for COVID-19 since the vaccination. On 19Jan2021 03:45, the patient experienced diarrhea, chills, fever of 101.8 and muscle pain. No treatment was received for these adverse events. Outcome of the events diarrhea, chills, fever of 101.8 and muscle pain was not recovered. The events diarrhea, chills, fever of 101.8 and muscle pain were considered non-serious. No follow-up attempts are possible. No further information is expected.

Moderate rash for 24 hours, headache for 24 hours and fever for 48 hours along with nausea, additional notes not sure if rash is due to shrimp allergy

Severe headache that made face and neck and arms tingle, stiff neck, pressure in face, head, eyes, neck and arms; bodily aches; fatigue (these symptoms do happen to me occasionally due to pre-existing fibromyalgia, however after the 2nd vaccine dose these symptoms were the most intense I had ever experienced); nausea

I woke up at 1:30am with nausea, chills, sweating, and diarrea. I went to the bathroom and vomited, my vision started darkening. After some time sitting on the toilet I stood up to wash my hands and reach for a hair tie to put my hair up because I was sweating profusely. I felt my vision darkening again and fell to the ground. I never lost consciousness and laid on the ground for a few seconds. I felt my stomach begin to churn again so I got up and sat on the toilet and began having diarrhea again. I texted my sister to come upstairs and bring me a Tylenol and some peppermint oil for my stomach. I took 1000mg of Tylenol, rolled peppermint oil on my stomach and stayed sitting with a cold towel on my head. I was then able to stand up and go back to bed at around 3am (shortly after taking the Tylenol). The next morning I woke up at around 8:30am, still feeling fatigued and mild chills. The diarrea and nausea are gone.

Pretty severe nausea began around 2/5/2021 at 9:00 PM and then I woke up on 2/6/2021 at 0300 with severe diarrhea.

After second dose pain at injection site; chills; diarrhea; GI upset; unwell feeling; This is a spontaneous report from a contactable Other Health Professional reported for herself. A 27-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number unknown), via an unspecified route of administration left arm, on 20Jan2021 at SINGLE DOSE for covid-19 immunisation. Medical history reported as none. No reported allergies to medications, food or other products. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Facility where the most recent COVID-19 vaccine was administered as at the hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient is not pregnant at vaccination time. The patient's concomitant medications were not reported. The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 30Dec2020 on the left arm. The patient experienced after second dose, pain at injection site, chills, diarrhea, GI upset, and unwell feeling on 20Jan2021 21:00. No treatment was given for the events. Outcome of the events was unknown. The reporter assessed the events as non-serious. Information on the lot/batch number has been requested.

Rash to face started 2/9/21 evening incontinence of urine, 2/9/21 overnight nausea, stomach pain 2/8/21 daytime/afternoon

first 3 days after injection she hovered around 98.8 fever. accompanied with chills, intense muscles pain all over, and it moved around. like sometimes she felt like an elephant on her lap., lower backpain , head pain, itching all over on and off. rash on her left arm and all along the inside of her arm all the way down for two days and on third left side of head. Day 3 pain with chewing, numbness on the left side inside the mouth with swallowing, combination of numbness and pain on left cheek. pain on the left side of face, neck cheek and chaw line. the neck was numb to touch and didn't feel cold or hot on left side. popping in her ear and inside mouth like pop rocks. and lots of throbbing in the TMJ joint. I could touch it and i could feel the throbbing in my finger. lasted until day 8 and then resolved slowly a little bit each day. was diagnosed with modified bells paulsey. with sensory involvement and didn't treat with steroids. and able to swallow but it felt numb. FaceTime with the INT to gather this info

I took my second dose of the vaccine (Pfizer) on February 8, 2021. I started to get a headache later that evening and later that night I started to get chills and feel very cold with aches. I was exhausted and still had a headache as well. That morning on the 9th I had to call out, I still felt achy with a headache that lasted all day. I contacted my supervisor and also employee health. I then again had to call out on the 10th because of nausea and a headache that persisted that morning. It wasn't until later that day on the 10th that I felt better than the previous day. I also contacted my supervisor again and employee health.

Headache with intermittent nausea throughout the day (4am until asleep at 10pm) that limited my daily activities. The headache was severe enough to wake me from sleeping at 4am, kept me from going back to sleep, made me feel intermittently nauseous, and was not completely relieved by a 650 mg dose of Tylenol taken in the afternoon. I didn't feel well enough for my daily tasks, and took a 2 hour nap without headache relief. I was 22 weeks 4 days pregnant the day of the headache/nausea, estimated due date 06/13/2021. This is my first pregnancy that is considered low-risk with a healthy course so far (and regular prenatal care). I had nausea the first 12 weeks of pregnancy, followed by about 6 weeks of daily mild headaches (weeks 12-18). This headache was more severe than I had experienced thus far during my pregnancy, but still manageable. This event was unusual as I have been feeling well since week 19 of pregnancy.

fever 120; vomit to dehydration point; vomit to dehydration point; a lot of discomfort; hot feeling inside of my body like I was burning; This is a spontaneous report from a contactable consumer (patient). A 27-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; brand: Pfizer; lot unknown: true) via an unspecified route of administration at arm right on 03Feb2021 at a single dose for COVID-19 immunization. The patient was not pregnant. Historical vaccine included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE: brand: Pfizer; lot unknown: true) at left arm on 13Jan2021 at 04: 45 PM at a single dose for COVID-19 immunization. Other medical history included asthma and known allergies: penicillin. Concomitant medications the patient received within 2 weeks of vaccination included ascorbic acid (VITAMIN C) and multivitamins for women. No other vaccine in four weeks. 2 hours after vaccination the patient started with fever 120 (no units specified) and a lot of discomfort; early morning she had vomit to dehydration point, hot feeling inside of her body like she was burning. She went to urgency room. Treatment received for the adverse event included received electrolytes for dehydration and ondansetron (ZOFRAN, reported as Zofram). The event start date was reported on 03Feb2021 at 01:15 PM. The outcome of all events was resolving. No COVID prior vaccination and no COVID tested post vaccination.

Nausea and vomiting as well as cramping that lead to being unable to eat for a week. After a week passed, was admitted to hospital for dehydration and to make sure GI problems were nothing more serious

anaphylactic like reaction immediate flushing, redness, itching, disseminated, irregular breathing, nausea, dizziness,

intense upper stomach pains (difficult time bending over, etc); Difficult time breathing/shortness of breath; This is a spontaneous report from a contactable healthcare professional. This 27-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number EL3247) intramuscularly in the left arm on 25Jan2021 (at the age of 27-years-old) at 09:00 as a single dose for COVID-19 immunization. The patient's medical history was not reported. The patient had no known allergies. Prior to vaccination the patient was not diagnosed with COVID-19. Concomitant medication included escitalopram oxalate (LEXAPRO) from an unknown date for an unknown indication, dicyclomine from an unknown date for an unknown indication, doxycycline from an unknown date for an unknown indication, levothyroxine from an unknown date for an unknown indication, birth control from an unknown date for an unknown indication and women's multivitamins from an unknown date for an unknown indication. The patient had not received any other vaccine within 4 weeks prior to the vaccine. On 26Jan2021 at 08:00 the patient experienced intense upper stomach pains (difficult time bending over, etc.). Additionally, she experienced a difficult time breathing/shortness of breath. The patient reported the events resulted in an emergency room or urgent care visit. It was unknown if the patient received treatment for the events. The clinical outcomes of intense upper stomach pains (difficult time bending over, etc.) and a difficult time breathing/shortness of breath were recovering. It was also reported that since the vaccination the patient had tested negative for COVID-19 on 26Jan2021 via nasal swab and polymerase chain reaction tests.

My last period started Tuesday Feb 2nd and did not stop until 14 days later, more than double my usual menstrual cycle. It seemed pretty normal and painless, but then on 8th day I was surprised to find myself still bleeding . It was a darker color around then, but then became brighter and I noticed myself passing clots when I went to the restroom that were loose, but about the size of a quarter or half dollar. I did not bleed through any menstrual pads, but the return of bright red after it being a darker red that im used to at the end of a period had me concerned. I was in slight discomfort around my uterus/bowels and I couldn't tell if it's my body recovering from the vaccine, or something else. I received my second dose of the COVID-19 vaccine 2/11/21 (Pfizer) and stayed home from work as I had a fever/headache/chills (this was not unexpected to me, my coworkers had the same symptoms). Family medical history: grandmother (dad's mom) in remission from stage 4 uterine cancer about 5 years ago. Mom had endometriosis at 45 and had a hysterectomy.

Fatigue - 4 PM - 02/26/2021-Present Nausea - 5 PM - 02/26/2021-Present Headache - 5 PM - 02/26/2021-Present Inject Site Soreness - 5 PM - 02/26/2021 Increase in Abdominal pain - 5 PM - 02/26/2021-present 101.2 Fever - 5 PM - 02/26/2021-02/27/2021. Lowered to 100.1 2/28/2021-present. Muscle aches - 6 PM - 02/26/2021 - lasted through the night only Dizziness - 10 PM - 02/26/2021-present Dry throat and mouth/unquenchable thirst - 10 PM - 02/26/2021-present Loss of voice (no sore throat) - 11 PM - 02/26/2021 Heart racing - 02/27/2021 since waking up - lasted about 30 hours Rash on left shoulder and arms. Itchy. 2/28/2021 - 9 AM to present

Stomach pain. Diarrhea. Headaches. Nausea. Wheezing. Troubling breathing. Mucus. pain in lungs when breathing.

arm soreness 3 hrs after vaccination; fatigue, chills, and frontal headache, and body aches began 6-8 hours after vaccination; sweats and fevers began 10-12 hours after vaccination and lasted 24hours after start of fevers; lightheadedness and near syncopal event 20hrs after vaccination; severe nausea around 20 hours after vaccination. Took 500mg Tylenol every few hours with very minimal relief. Fevers remained around 100-102 with medication.

Shivers and shakes starting 9 hours after 2nd dose (Fri). Fever of 99.9 the next morning (Day 2 - Sat) with cold sweats and shakes all day. On day 3 (Sun), no fever but still extreme exhaustion and tiredness. Throwing up also started on Day 2 around 2pm and could not keep anything down. On day 4 (Mon), still extreme exhaustion that lasted until about noon. Was finally able to eat something at noon and felt back to normal by 2pm on Monday.

Angioedema; swelling; Difficulty breathing; Tight chest; Facial flushing; Dry eyes and unsettled stomach; Dry eyes and unsettled stomach; This is a spontaneous report from a contactable nurse. A 27-years-old non-pregnant female patient started treceive bnt162b2 (BNT162B2), Lot number: EL9266, intramuscular in left arm on 15Feb2021 at 0900 (at the age of 27 years-old) for COVID-19 immunzation. The vaccination was administered at a workplace clinic. Medical history included Allergy/Sports-Induced Asthma, Lactose Intolerant and food allergies of Kiwi, Lactose Intolerant, Cherry. The patient had a positive COVID-19 test prior to vaccination on 14Nov2020. There was no other vaccinations given within 4 week and concomitant medications within 2 weeks included ethinylestradiol, ferrous fumarate, norethisterone acetate (LO LOESTRIN FE), cetirizine hydrochloride, pseudoephedrine hydrochloride (ZYRTEC-D), vitamin c [ascorbic acid] (VITAMIN C [ASCORBIC ACID]), fish oil (FISH OIL). On 15Feb2021 at 10:00, the patient experienced Angioedema/swelling, Difficulty breathing/tight chest, facial flushing, dry eyes and unsettled stomach. Experienced symptoms of flushing 1hour post-vaccination. The clinical course was as follows: She reported that she experienced symptoms of flushing 1hour post-vaccination. About 4 hours later swelling persisted and took Zyrtec to alleviate symptoms, which provided minimal relief. 24 hours post vaccination resulted in ER admission advised per Occupational Medicine at (name). IV SoluMedrol, Bendaryl and Pepcid administered. Overall stay in ER 3 hours. On 17Feb2021, 24 hours post admission rebound symptoms occurring with facial flushing and swelling. Will repeat allergy medication to relieve symptoms PRN. The clinical outcome of the events was recovered with sequalae (as reported by patient: recovered with lasting effects).

5 minutes after injection I experienced a metallic taste in mouth and slight tightening of throat. I waited 20 minutes in observation and spoke to nurse and PA who assured me I should be fine if I had no history of anaphylactic shock. 20 minutes later I still felt tightness in my throat, metallic taste in mouth, headache, and now slight difficulty swallowing, at which time I used my Albuterol rescue inhaler. Tightening in throat resolved within an hour. Metallic taste and headache is still present +2 hours after injection.

Light-headness within forty five minutes - a little dizzy; tiredness; nauseous; swelling on injection site - it was a little worse then on the first dose (I forgot to mention that I had swelling on the injection site after the first dose, too). These symptoms lasted for about two weeks. I took Benadryl to help with the symptoms - it helped the symptoms to let me to sleep. A week and a half before I took the second COVID vaccine, I had a TB test done. Exhaustion is still there and I still have nausea. Dizziness has been gone since second week of the 2nd dose of vaccine. Swelling on the injection site is gone. I had a doctor visit - Video visit with clinic and the dr recommended bedrest - February 11th or 12th - no meds given. I'm due Sept 26, 2021. This is my fourth pregnancy - I had my daughter who is eight years old; an abortion; had my son who is five and he was born pre-term due to lack of fluids in the stomach - 4 lbs 5 oz. and now this pregnancy.

Really bad headache, fatigue, I was throwing up, I was running about 100 fever but it didn't go higher than that. Those symptoms lasted about a week and a half. Talked to healthcare provider with video chat - put me on bedrest. I had a positive pregnant test about three days after the first dose of COVID vaccine. And went to the Hospital about 1 week and 1/2 after finding out. I'm due Sept 26, 2021. This is my fourth pregnancy - I had my daughter who is eight years old; an abortion; had my son who is five and he was born pre-term due to lack of fluids in the stomach - 4 lbs 5 oz. and now this pregnancy. Had the second dose of vaccine, I think of February 9, 2021.

Exactly 14 minutes after injection, felt dizzy and nauseous. Fainted, had convulsive syncope for 1 minute, lost voluntary control of bodily function (urinated), woke up, and vomited multiple times. Vomiting lasted from 10:35am - 1:10pm. Also had diarrhea twice in between vomiting, and was shaking occasionally.

Headache; fever; chills; nausea; vomiting; This is a spontaneous report from a contactable consumer (patient). A 27-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 03Feb2021 15:45 at single dose in left arm for COVID-19 immunization. Medical history included allergies to Zithromax. Concomitant medication included topiramate. The patient previously received first dose of BNT162B2 on 13Jan2021 03:45 PM in left arm. The patient had no covid prior vaccination. The patient had no covid tested post vaccination. The patient experienced Headache, fever, chills, nausea, vomiting. Headache began about 2 hours after 2nd dosage administered (03Feb2021 17:45). Rest of symptoms began about 12 hours after headache. Vomiting, fever, chills and nausea all lasted about 8 to 10 hours. Headache lasted about 24 hour. No treatment was received for the events. The outcome of all events was resolved on 04Feb2021. Information about lot/batch has been requested.

Nausea, low grade fevers, lethargy ,Psoriasis Rosasea a few days after but dermatologist didn't think it was from the vaccine

received first dose on 27Dec2020 and second dose on 13Jan2021; received first dose on 27Dec2020 and second dose on 13Jan2021; chills; fever; dizziness; headache; nausea; lack of appetite; fatigue; hot flashes; This is a spontaneous report from a contactable nurse (patient). A 27-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK4176, ), intramuscular in the Left arm on 13Jan2021 13:30 PM at single dose for covid-19 immunisation. Patient was not pregnant. Medical history was None. No known allergies. No other medical history. No other vaccine in four weeks. Other medications in two weeks included Birth control. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number=EH9899, administrator route=Intramuscular, vaccine location=Left arm) on 27Dec2020 at age of 27 years old for COVID-19 immunization and nothing after the first shot. The night of the second shot (13Jan2021) patient had chills, fever, dizziness, headache, nausea, lack of appetite, fatigue, and hot flashes until the following two days (15Jan2021). Then dizziness, fatigue, nausea, lack of appetite, chills, and hot flashes for about a week (in Jan2021). No treatment for the adverse events. No covid prior vaccination. No covid tested post vaccination. The patient administered vaccine in Doctor's office/urgent care. The outcome of 'received first dose on 27dec2020 and second dose on 13jan2021' was unknown, of other events was recovered.

First, I had moderate pain in my right arm and near the injection site. After the first dose, my right arm and hand became numb with loss of feeling or touch. This lasted for most of the evening, about 12 hours after vaccination. The injection site and the muscle were in a lot of pain, which climbed up into my neck muscle. I did not have any fever or chills. For the past several days, I have become fatigued very easily. Lastly, my lower abdominal area has become sore with discomfort. I have never experienced this before, and I am not currently menstruating either. Tylenol makes it better, and resting on my back and excess movement makes it worse.

I was nauseous after the shot but it may have been hunger and nerves. I had itchy skin for a little bit on my face and arms. Then it went away. I got home around six pm. I had to go to the bathroom and first go was a mix of diarrhea and solid stools. Then as soon as I left the bathroom, I had to go back. It was fully blown diarrhea. Then I kid you not, my period came on at the same time. It is usually unpredictable but I wanted to add it just in case. And my arm became really really sore around 8pm and last night I could barely move it from the pain, or lift it. This morning it is still sore...and hurts to put pressure on .

Patient discharged from vaccine event asymptomatic at 1645, returned to work, then came back to vaccine tent at 1800 stating she had a "splitting headache, was cold, clammy and nauseated." Vital signs SPO2 99% HR 72 and regular, Blood pressure 148/98, skin dry, hands cool, at this time denying nausea, still with complaints of headache. At 1830 HR 75 regular heart rate remains regular, SPOS 99%, denies any airway issues, declined water or crackers, wanted to go home.

"CC: Sore throat Symptoms: Cough:no Shortness of breath: no Difficulty breathing: no Loss of taste: no Loss of smell: no ------------------------ Fever > 100.4: no Subjective fever: Chills: no Rigors: no Myalgias: no Headache: yes Sore throat:yes Diarrhea: no Nausea/Vomiting: no Nasal congestion/rhinorrhea:yes Additional symptoms:PND"

Began feeling sick after injection. Low fever, fatigue for day of injection and day after. Day 3 felt normal, but day 4 began feeling sick again with no appetite, nausea and chills. At 5:30 I passed out and remained unconscious until my mother found me on the floor and then had a seizure lasting about 2 minutes. I was unconscious for at least 30 minutes. I have had seizures in the past, but never anything close to this.

Headache, low-grade fever, nausea, and muscle aches began a few after injection and continued until about 72 hours after injection

The day after the vaccined was administered, patient was unable to produce any saliva and inside of cheeks were red, swollen. This lasted 3 days. After that, patient experienced headaches, nausea, cough that stopped on 10MAR21. Patient had no symptoms of illness prior to vaccination on 24FEB21, on 04MAR21 patient tested positive for covid-19.

Sore Arm; Nausea; Light Headedness; This is a spontaneous report received from a contactable consumer (patient herself). A 27-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection and lot number EN5318) via an unspecified route of administration to left arm on 04Feb2021 at single dose for COVID-19 immunization. Patient medical history and concomitant medications were not reported. It was reported as patient experienced with Sore Arm, Nausea, Light Headedness on 04Feb2021. Patient did not receive any treatment for events. Outcome of events was recovered on an unspecified date. No follow-up attempts are possible. No further information was provided.

body aches; headache; nausea; a low-grade fever; This is a spontaneous report from a contactable consumer (patient). A 27-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3247) via an unspecified route of administration on 16Feb2021 12:30 at single dose on left arm for covid-19 immunisation. The medical history was none. Historical Vaccine included first dose of of bnt162b2 (lot number: EL3247) on 26Jan2021 12:30 at single dose on left arm for covid-19 immunisation. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medication included vitamin D, and ethinylestradiol, ferrous fumarate, norethisterone acetate (JUNEL FE). The patient experienced body aches, headache, nausea and a low-grade fever on 17Feb2021. About 12 hours after the second dose, the patient started to have body aches, a headache, and nausea. This lasted for about 18 hours. At about 24 hours post-shot, she took her temperature and had a low-grade fever. She took 400 mg of ibuprofen at about 24 hours post-shot and that helped ease the side effects. By 30 hours post-shot, she was able to return to normal activies. Since the vaccination, the patient has not been tested for COVID-19. The outcome of events was recovered on 17Feb2021.

3/20/2021 Patient was observed post Covid-19 immunization for 30 minutes based on pre-vaccination screening . During the observation period, she experienced an adverse reaction with the following symptoms: , she reports trouble swallowing Assessment : Time of assessment 0521pm. ., no swelling of face or mouth area noted Actions taken: Observed for 30 minutes, VS taken , meds and water given Medications administered: Famotidine (Pepcid) 10 mg by mouth. Time: 0515pm. Administered by ,.Benadryl 25 mg po x1, water given Disposition: Reports no further symptoms of adverse reaction after observation for 30 minutes. Discharged home. Immunizations Administered Name Date Dose VIS Date Route Pfizer COVID-19 Vaccine 3/20/2021 4:50 PM 0.3 mL 12/11/2020 Intramuscular Manufacturer: Pfizer, Inc Lot: ER2613

Decreased alcohol tolerance (one glass of wine was like I drank three) Nausea (nearly vomited several hours after being home)

1405: Approximately 5 minutes post vaccination patient experienced light headedness, nausea," I could feel my heartbeat everywhere". Patient A & O x4, skin pink, warm and dry, Allergies: Morphine, Amoxicillin PMHx: patient denies Meds: Patient denies Patient placed on gurney and assessed by EMS and Physician on duty and continued observation in first aid area. Patient given water, and reported that symptoms were improving 1441: patient able to sit upright without symptoms. Cleared for to discharge home by Physician on duty.

Approx. 8 hours after the vaccine I experienced headache, diarrhea, chills and a low grade fever. Also experienced severe pain at the injection site, that worsened over the evening. All symptoms continued through the evening. Also experienced night sweats. The following morning, headache and mild chills were present, but other symptoms had abated. Had minor brain fog. Those symptoms resolved over the course of the day. All symptoms, except night sweats, have cleared up. Night sweats are ongoing.

One day after vaccine developed diarrhea with nause and vomiting. She also reported general malaise similar to "Influenza like symptoms". She stay at bed and improved from the general malaise symptoms but persisted with nausea and vomiting. On day 3, she reported at night that her pulse Ox dropped to 88% and was taken to ER. She was admiited with suspected atelectasis of left lower lobe abd possible pneumonia which is difficult to evaluate due to her chronic lung condition. She had improved and is no longer having vomiting or general malaise and expected to be discharge home soon.

Patient complained of itching and hives 5 minutes post vaccination. Benadryl 50 mg IM @RD given at 1:32pm. Patient felt dizzy. Laid down with feet up. Patient complained of difficulty swallowing and breathing at 1:47pm. Epipen administered on left outer thigh intramuscularly. 911 called. Transferred to Hospital via ambulance at 2:01pm. Vital signs: 1:25pm BP 110/75 O2 sat 98%, 1:30pm BP 110/80 HR 86bpm; 1:54pm BP 120/95 , HR 137 bpm, O2 sat 98%; 1:57pm HR 124 bpm. Lungs clear to auscultation. Called patient at 6:12pm for follow-up. Patient is still in the hospital for observation. She received treatment and under observation.

Patient felt faint, lightheaded, nauseous approximately 5 minutes post vaccination. Tx: Laid supine, EMS evaluation, vitals Pt refused EMS transport and further care, pt recovered

Soreness at injection site started 3 hours later. Fever over 100F, aching muscles, nausea, fatigue, headache all started at 7am the next day.

appendicitis/abdominal pain; This is a spontaneous report from a contactable consumer (patient) reported that a 27-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6208), via an unspecified route of administration, administered in arm left on 12Mar2021 09:00 as a single dose (at the age of 27-years-old) for covid-19 immunization. The vaccine was administered at the clinic. The patient's medical history and concomitant medications were not reported. On 12Mar2021 at 6:00 pm, she started with abdominal pain that continued through Saturday (13Mar2021), and Sunday (14Mar2021) morning she went to clinic, they told her that she had appendicitis and she should go to hospital for a test. She went to the hospital, they ran a contrast test and she was diagnosed with appendicitis on Mar2021. She had the operation on Monday (15Mar2021) and she was recovering. The reported event resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The patient needed operation. The patient was hospitalized on Mar2021.

headache; itches at the injection site; felt a little nauseous; This is a spontaneous report from a contactable Other HCP. A 27-year-old non-pregnant female patient received first dose of bnt162b2 (BNT162B2; Solution for injection; Lot number: EJ1686), ), intramuscularly on Left arm on 20Jan2021 13:30 at single dose for covid-19 immunization. Other medical history includes Eczema, hypoglycemic, anemic. Known allergies includes Rondec. I had a baby. I had been weening from breastfeeding in January. As a result I start my menstrual cycle around the same day as I got my first shot. I sort of had a headache before the shot and definitely had one later that day and the next after the shot. I also felt a little nauseous the next day after receiving the shot. I also started my menstrual cycle again 2 weeks later (around February 8) which would be 2 weeks early. I've been on a birth control pill for 6 months and before having a child, would never had irregular periods. My left arm itches at the injection site for maybe 3 or 4 days. Adverse events was start date on 21Jan2021. And did not received any treatment. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient diagnosed with COVID-19 was unknown; Patient has not tested positive for COVID-19 since having the vaccine. The outcome of the event was "Recovered". Information on the batch number has been requested.

anxiety attack/she did get pretty anxious easily and that probably exacerbated it; Chest pain; Chest heaviness; Abdominal pain; eyelid got puffy/puffiness mostly on her upper eyelid of her left eye; had eye puffiness in her left eye; This is a spontaneous report received from a contactable nurse (patient). This 27-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 10Mar2021 10:15 (Batch/Lot number was not reported, reported as "one number on there is EN and then she does not know if it is a G or 6 and then 204") as a single dose for COVID-19 immunization. Medical history included ongoing anxiety from 2020, ongoing acid problems from 2020, high cholesterol levels from 2020 (she was not prescribed any medication and the advice given was just for diet and exercise), and ongoing gallbladder problem for years. There were no concomitant medications. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No additional vaccines administered on same date of the Pfizer suspect. On 10Mar2021, patient had eye puffiness in her left eye. Patient asked if it is safe to take the second dose. Her eyelid got puffy which began 30 minutes after having the Pfizer COVID Vaccine and it is not ongoing but resolved completely after a few minutes. She did not require treatment for the eye puffiness and the puffiness was mostly on her upper eyelid of her left eye. Patient stated that she does not know in terms of causality if the Pfizer COVID vaccine is related to the reported events and was worried because a week after she got the vaccine, she had other symptoms and was not sure if they are connected with the vaccine. She also reported that she does not think the eye puffiness itself is that serious but it is medically significant and the other symptoms she had were chest pain, chest heaviness, and abdominal pain. These symptoms are not ongoing anymore and began around Friday, 19Mar2021 and resolved after a couple of hours of when they began. For the chest pain, chest heaviness and abdominal pain, she just took an antacid Prilosec for treatment. She thought about going to the emergency room but also thought she was having an anxiety attack and was close to having to go to the emergency room that night. She did get pretty anxious easily and that probably exacerbated it. AEs did not require a visit to emergency room or physician office. Outcome of the events had eye puffiness in her left eye and eyelid got puffy/puffiness mostly on her upper eyelid of her left eye was recovered on 10Mar2021, of the event "anxiety attack/she did get pretty anxious easily and that probably exacerbated it" was unknown, and of the other events was recovered in Mar2021. Information on the lot/batch number has been requested.; Sender's Comments: Based on the information provided, the contributory role of the suspect bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) to reported events is possible.

vomiting 7 times over 2 days diarrhea 30+ times over 4 days fever around 103 for 4 days intense stomach pain ruptured appendix and appendectomy

About 15 minutes after injection patient reporting shortness of breath , difficulty swallowing. throat felt swollen and tingly sensations. On assessment patient clear but diminished breath sounds, thready/weak pulse, swollen lips , BP 130/80. At 1359 pharmacy gave first dose of Epi in left leg, pt symptoms only mildly improved, then second dose of epi given at 1406. ER rapid response on site to take patient to ER and assume care.

Woke with up chest, arm and jaw pain on 03/21/2021. Presented to the ED. Her initial EKG was negative for any acute changes but her troponin was elevated. Cardiology was consulted. Her echo was negative for cardiomyopathy or hypertrophy. But after her troponin continued to rise she was taken to the cath lab to look for ischemia. Her cardiac angiography was negative for obstructive disease, and coronary arteries were completely normal. Had low magnesium and potassium- so started on oral supplementation. Discharged on 03/22/2021 with nitroglycerin (which was not helpful and made her feel worse/nauseated) and to follow up with outpatient cardiac MRI and cardiology. This imaging revealed significant myocardial edema consistent with myocarditis. 04/01/2021 Per Cardiology: -Given that the patient had covid 19 back in November 2019 I believe she may have had a low yield subacute myocardial infection at that time that was somehow exacerbated by her 1st covid vaccine. Therefore, after some consideration and careful discussion I am advising against the 2nd vaccine at this time. -No physical exercise for 6 months given her current myocarditis and family hx of sudden cardiac death -May trial PRN NSAIDS for pain relief -Recommend birth control and no pregnancy until at least after her follow up cMRI -Follow up in 6 months with cMRI prior

Fever up to 102 for 2 days and periodically for 2 weeks after bone ache for first two days and a severe flare up 2 weeks later diarrhea for first week Chills for two days and off and on after Brain fog ongoing since shot

Body aches, fever up to 102.6°, chills, bad headache, tiredness, nausea, loss of appetite Using ice and taking Tylenol every 4 hours

Fever- lasting 24hrs, started 14hrs after shot Body aches- lasting 24hrs, started 12hrs after shot lightheaded/dizziness- lasting 2-4 hours, started 20hrs after shot Nausea- lasting 2-4 hours, started 20hrs after shot severe headache- lasting over 24hrs, started 12hrs after shot Fatigue- lasting over 24hrs, started 5 hours after shot

Fever; Chills; Body aches; Migraine; Nausea; Dizziness; This is a spontaneous report from a contactable consumer (patient). A 27-year-old female patient (pregnant: No) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via unspecified route of administration in left arm on 03Feb2021 (lot number: EL9269) at 13:15 at single dose for COVID-19 immunisation. The relevant medical history included fibromyalgia. Concomitant medications included spironolactone. The patient previously received the first dose of BNT162B2 on 13Jan2021 (lot number: EL3249, administration time: 12:45PM, vaccine location: Left arm) at the age of 27 years old for COVID-19 immunisation. The patient experienced fever, chills, body aches, migraine, nausea, dizziness on 04Feb2021 at 09:00 AM. No treatment received for the events. The outcome of the events was recovered on an unspecified date in Feb2021.

Woke up with extreme nausea in middle of the night (2:30 AM) and passed out/fainted in the restroom. Unsure of how long episode lasted.; Woke up with extreme nausea in middle of the night (2:30 AM) and passed out/fainted in the restroom. Unsure of how long episode lasted.; Woke up with extreme nausea in middle of the night (2:30 AM) and passed out/fainted in the restroom. Unsure of how long episode lasted.; This is a spontaneous report from a non-contactable consumer (patient). A non-pregnant 27-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 2 via an unspecified route of administration, administered in the left arm on 24Apr2021 at 09:00 (Batch/Lot Number: EW0164) at 27-years-old as a single dose for COVID-19 immunization. The patient did not receive any other vaccine within four weeks of the suspect vaccine. The patient did not have COVID prior to the vaccination. Medical history included Ehler-Danlos Syndrome, migraine, gastroparesis, and fibromyalgia; all from an unknown date and unknown if ongoing. Concomitant medications included colecalciferol (VITAMIN D); gabapentin (MANUFACTURER UNKNOWN); promethazine (MANUFACTURER UNKNOWN); ascorbic acid, betacarotene, calcium sulfate, colecalciferol, cyanocobalamin, ferrous fumarate, folic acid, nicotinamide, pyridoxine hydrochloride, retinol acetate, riboflavin, thiamine mononitrate, tocopheryl acetate, zinc oxide (PRENATAL VITAMINS); all taken for an unspecified indication, start and stop date were not reported; received within two weeks of the suspect vaccine.. The patient previously took bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) for COVID-19 immunization (Lot number: RE8732; Anatomical Location: Arm Left; Dose Number: 1) on 03Apr2021 at 27-years-old. On 25Apr2021 at 02:30, the patient experienced: woke up with extreme nausea in middle of the night (2:30 am) and passed out/fainted in the restroom. Unsure of how long episode lasted. (medically significant); with no treatment taken. The clinical outcome of the events was recovered on an unspecified date. The patient was not tested for COVID post vaccination. No follow-up attempts are possible. No further information is expected.

From 0-24 hours post injection, I had soreness at injection site. At 18 hours post injection, I had abnormal back pain (lasted about 30 minutes). At 29 hours post injection, I had rapid onset chills (lasted 3 hours) and fever (highest measurable was 100.3, lasted about 1 hour), feeling faint (15 minutes), nausea (15 minutes).

Vomited suddenly without knowledge of being nauseous; only happened once but nausea remained after. After about an hour and a half muscle aches and headache kicked in.

tachycardia, nausea, itchiness, tongue swelling (voice change)==> all lasted from 1920pm to 2050pm. Given Benadryl IV and NaCl. Pt in the ER about 2.5 hours.

Diarrhea; nausea; This is a spontaneous report from a contactable other hcp. A 28-year-old female patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# EK5730), intramuscular from 28Dec2020 09:00 to 28Dec2020 09:00 single dose for COVID-19 immunisation. Medical history included haemochromatosis from an unknown date, rubber sensitivity from an unknown date. Concomitant medications included ethinylestradiol, norgestimate (SPRINTEC), trazodone, quetiapine fumarate (SEROQUEL), sertraline hydrochloride (ZOLOFT). Vaccine location was arm left. The patient experienced diarrhea on 29Dec2020 10:00, nausea on 29Dec2020 10:00. The action taken in response to the events for BNT162B2 was not applicable. Events outcome was not recovered. No follow-up attempts are possible. No further information is expected.

Nausea; racing heart rate; restlessness; Dizziness; Shaking; breathlessness; This is a spontaneous report from a contactable consumer reporting for herself. A 28-years-old female patient received bnt162b2 (BNT162B2 ; Lot # EK9231) vaccine , via an unspecified route of administration on 27Dec2020 at single dose for Covid-19 immunisation . Medical history included drug hypersensitivity to amoxicillin sodium on an unknown date and unknown if ongoing. There were no concomitant medications. The patient experienced about one minute and a half after receiving the vaccine racing heart rate on 27Dec2020 with outcome of recovered , restlessness on 27Dec2020 with outcome of recovered , dizziness on 27Dec2020 with outcome of recovered , shaking on 27Dec2020 with outcome of recovered , breathlessness on 27Dec2020 with outcome of recovering , nausea on 28Dec2020 with outcome of recovered. The patient underwent lab tests and procedures which included heart rate: racing on 27Dec2020. The patient received diphenhydramine (BENADRYL) to treat dyspnea.

Temp 102.6 while taking tylenol, headache muscle, Hr 140 01/05/21 chills, lightheadedness, 01/06 diarrhea

swollen lymph nodes on neck; pain in the injection site; general body fatigue; low grade fever; mild tummy ache; body aches; This is a spontaneous report from a contactable other health professional (other-HCP) (patient). A 28-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE: brand: Pfizer; lot number: EI0142) intramuscularly at left arm on 30Dec2020 at 06:30 PM at a single dose (dose number: 1) for COVID-19 immunization. Medical history included known allergies: trees, grass, pollen, certain flowers, indoor allergens (don't know specifics). No other medical history. The patient was not pregnant. Other medications the patient received within 2 weeks of vaccination included loratadine/pseudoephedrine sulfate (CLARITIN D-12), drospirenone/ethinylestradiol betadex clathrate (YAZ) and mometasone furoate (FLONASE). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Facility where the most recent COVID-19 vaccine was administered was at hospital. The patient experienced adverse events pain in the injection site, swollen lymph nodes on neck, mild tummy ache, body aches, low grade fever, general body fatigue; all occuring the day after injection, on 31Dec2020 at 06:15 AM. The events were reported as non-serious. Treatment received for events included tylenol took on 31Dec2020 at 8:40 PM. The outcome of event was not recovered. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.

After receiving vaccine, woke up around 3 am experiencing nausea, loss of vision x 1-2 minutes, syncope, difficulty breathing, numbness & tingling in hands and feet. Measured temperature of 102 F. Slept most of the next day and missed work x 1 day. The following day was improved but still with moderate fatigue and nausea. Took ibuprofen with some improvement.

During initial screening, patient did not report history of food allergies and the Screening form specifically asks for any past allergic reactions to vaccines or other injectable medications. Patient received vaccination without any problems. Patient came from Immunizations Clinic to post vaccination observation area with her chalk in no distress after 1min of receiving her 1st dose of Pfizer COVID Vaccine. She stated she felt like she was having difficulty swallowing. The patient denied allergy to Benadryl and 25 Mg was offered her immediately, which she took. Physician was at side by this time and EMS was notified. Co-workers with patent said her face appeared "puffy" Four minutes after initial symptoms her vitals were as follows: BP 118/79 Sao2 99% on room air HR 97 Physician ordered Epipen and EMS was arrived and placed patient on gurney. Epipen 0.3.mg IM delivered by paramedic. Six minutes after initial symptoms report wasgiven to EMS and patient was taken to the hospital.

Pt c/o shortness of breath 2.5 hours after vaccine. Also reports hives, headache, dizziness and nausea since last night.

About 12 hours after the shot, I had significant chills, body aches, fever, severe nausea that induced vomiting (unable to keep down water). 12 hours then after these symptoms is when things began to slowly subside. Just ended up missing work for two days.

Dizziness for hours; vomiting; sleepiness; This is a spontaneous report from a contactable healthcare professional. A 28-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular on the right arm on 30Dec2020 16:00 at single dose for COVID-19 immunisation. The patient had no medical history. There were no concomitant medications. The patient known allergies: amoxicillin. The patient experienced dizziness for hours, vomiting, sleepiness on 31Dec2020 22:00. The patient received no treatment. The outcome of the events was recovering. Information on the lot number has been requested.

Headache, Myalgia, Fever, fatigue, feels hot but temp is normal. Narrative: 12/28 onset of "feeling crummy" - fatigue and "really bad" headache. She went home after work and went to sleep. 12/29 onset of feeling "hot" but her temperature is normal. Body aches, slight headache, and feeling "clammy". She took ibuprofen on 12/29 and is currently at work. Employee reports she usually feels mildly ill the day after a flu vaccine but this adverse reaction is much worse than that. 12/30 - employee reports she developed diarrhea and a temp to 99. Continues to have body aches and mild headache. 12/31 all symptoms resolved.

Injection site soreness, fatigue/chills (day). Bad diarrhea at night.; Injection site soreness, fatigue/chills (day). Bad diarrhea at night.; Injection site soreness, fatigue/chills (day). Bad diarrhea at night.; Injection site soreness, fatigue/chills (day). Bad diarrhea at night.; This is a spontaneous report from a contactable other hcp reporting for herself. This 28-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) the first dose on 15Dec2020 14:00 (Lot # EK5730) in the left arm and the second dose on 04Jan2021 12:45 (Lot # EL1284) in the right arm, both via an unspecified route of administration at single dose for Covid-19 immunisation. Medical history included asthma and allergies to Penicillin and Oxycodone. Concomitant medication included omalizumab (XOLAIR), salbutamol sulfate (PROAIR [SALBUTAMOL SULFATE]), fluticasone furoate, vilanterol trifenatate (BREO ELLIPTA). On 04Jan2021 23:00, the patient experienced injection site soreness, fatigue/chills (day). Bad diarrhea at night. No treatment was performed. The outcome of the events was recovered. The patient underwent lab tests and procedures which included Nasal Swab, Covid test on 28Dec2020 was negative. The vaccine was administered at Hospital Facility. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination.

Mouth sores; This is a spontaneous report from a contactable other healthcare professional, the patient. A 28-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), lot Number: Er9231, via an unspecified route of administration on 30Dec2020 at 09:00 (at the age of 28 years old) as a single dose in the left arm for COVID-19 vaccination. Medical history included herpes simplex virus 1 from an unknown date, and known allergies to some fruits and vegetables (mild itching), and Neosporin. The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medication included Benzoyl peroxide and tretinoin face cream, and vitamin D, all for unknown indications from unknown dates and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. The vaccine was given at a hospital. On 31Dec2020, the patient experienced mouth sores. Treatment was not received for the event. It was also reported that since the vaccination, the patient has been tested for COVID-19 using a nasal swab on 31Dec2020, with results of negative. The clinical outcome of mouth sores was recovering.

Some nausea; Got a pulsating headache; Shortly after receiving the vaccine I felt a flushed feeling in my cheeks.; My left arm also was extremely hard, sore, and tender/swollen.; My left arm also was extremely hard, sore, and tender/swollen.; This is a spontaneous report from a contactable nurse. A 28-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EH9899), intramuscular on 22Dec2020 16:00 at single dose at arm (for confirmation) for COVID-19 immunization. Medical history included anxiety. The patient's concomitant medications were not reported. On 22Dec2020 17:00, Shortly after receiving the vaccine the patient felt a flushed feeling in her cheeks. The patient's left arm also was extremely hard, sore, and tender/swollen. About an hour afterwards, 18:00 I got a pulsating headache that lasted for 3 days. It was only mildly relieved with Tylenol and ibuprofen. It felt similar to a migraine and accompanied with some nausea on 23Dec2020 day 2. The patient received treatment for the events. The outcome of the events was recovered on an unspecified date in Dec2020.

Sudden development of hot flashes with sweating and blurry vision- felt like I was going to faint.; Sudden development of hot flashes with sweating and blurry vision- felt like I was going to faint.; Sudden development of hot flashes with sweating and blurry vision- felt like I was going to faint.; Sudden development of hot flashes with sweating and blurry vision- felt like I was going to faint.; Tingly sensation in arms and then some nausea and general feeling of weakness with persistent headache.; Tingly sensation in arms and then some nausea and general feeling of weakness with persistent headache.; Tingly sensation in arms and then some nausea and general feeling of weakness with persistent headache.; Tingly sensation in arms and then some nausea and general feeling of weakness with persistent headache.; This is a spontaneous report from a contactable nurse. A 28-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), Lot number= ELO140, via an unspecified route of administration, in the right arm, on 31Dec2020 at 13:45 (at the age of 28 years-old) as a single dose for COVID-19 immunization. The vaccine was administered at a hospital. Medical history included polycystic ovarian syndrome. There were no concomitant medications. The patient had not received other vaccines in 4 weeks nor taken any other medications in 2 weeks. Prior to the vaccination the patient was not diagnosed with COVID-19. On 01Jan2021 at 0700 the patient experienced hot flashes with sweating and blurry vision- felt like she was going to faint, tingly sensation in arms and then some nausea and general feeling of weakness with persistent headache. The clinical course was as follows: Sudden development of hot flashes with sweating and blurry vision- felt like she was going to faint, tingly sensation in arms and then some nausea and general feeling of weakness with persistent headache. The vision blurring and hot flashes resolved within 15-20 minutes but the fatigue, headache and nausea persisted throughout the day. The patient was not hospitalized for the event nor was treatment administered. The clinical outcome of the hot flashes with sweating and blurry vision- felt like she was going to faint, tingly sensation in arms and then some nausea and general feeling of weakness with persistent headache. Since the vaccination, the patient has not been tested for COVID-19.

Approximately 4 hours after the vaccine administration, I started getting symptoms that started mild and became severe including: headache, dry cough with chest pressure, dizziness/lightheaded, joint pain, body aches, fatigue, and chills. At 5:30 pm I started getting a fever, that started at 100.5 then increased to 103.3 by 8:30 pm. I was also nauseous and vomited once. I was tested the next morning for influenza and COVID and was negative. My fever came back down to 98.8 around 12 pm the next day. Overall, symptoms lasted approximately 30 hours after the vaccine was administered. I was out of work the following day after the vaccine. Now, 2 days after the vaccine I am just mildly fatigued with a dry cough left.

Dizzy, lightheaded, vertigo, nausea, vision out of focus, unable to walk straight and have to stabilize myself on the wall. I have had 6 episodes lasting 3-24 hours. It has been over 2 weeks (since 12/26/2020 - now).

12/18 VACCINATION 12/23 CAME HOME AT 7:30 AM FROM WORK. MY BODY WAS HURTING, SORE. SLEPT. WOKE UP 9-10; VOMITING BODY ACHES, HA. WENT TO ER. COULDN'T KEEP ANYTHING DOWN, EVEN MEDICINE. GAVE ZOFRAN, COVID TEST (NEGATIVE) FELT LIKE I WAS KNOCKED OUT. DIDN'T GET OUT OF BED FOR DAY. TEMP GOT UP TO 102. WITH TYLENOL, IBUPROFREN. BODY WAS SORE. THESE SYMPTOMS ARE STILL PRESENT. LINGERING COUGH. 1/1/2021 FEVERS. LASTED 1-2 DAYS. MUNICEX FOR COUGH AS NEEDED. NOT 100% BETTER, MAYBE 95%

I am early pregnancy- I haven't even had an ultrasound yet to calculate an exact due date. I am approximately 6 weeks. About 12 hours after receiving the vaccine I became ill with body aches, chills, nausea, vomiting, general malaise and headache. I was sick until approximately 1530 on 1/10.

Mild headache about 6 hours after then by about 12 hours after dose had profound chills, body aches, severe nausea and temperature 99.8 F. I treated the nausea with Zofran with some improvement in nausea, but other symptoms continued. My max temperature (without antipyretic affecting) was 100.7 F with continued nausea, body aches, fatigue and headache until the 24 hour after vaccine time frame. After 24 hours, nausea had improved largely to just mild, mild headache continued and fatigue/body aches. Around 28 hours, temp was 100.2 F (outside of last antipyretic dose) with same symptoms. Now around 30 hours out with recent Motrin taken, my nausea is still mild, low appetite, improved body aches and less fatigue. I have not had any site reactions other than pain starting around 6 hours after injection. Course to come yet unknown.

About 2 hours after vaccine, experienced soreness down entire left arm. Later that evening low grade fever of 99.9, chills, headache, nausea and fatigue that persisted until Friday evening. Saturday I experienced a headache and nausea, loss of appetite and whole body fatigue and soreness in back, neck and arm. Headache, fatigue, loss of appetite and nausea persists till now (Monday/Day 4)

Fever, chills, headache, myalgias started around 10 pm worsened through the night. Fatigue the next day and nausea. Headache has persisted still have it currently. Have been hydrating and taking ibuprofen which helps

I woke up with chills and diarrhea . I started to sweat out of no where but I didn't have a fever, towards the end of the night I lost my taste for the next two days. I still had chills and was sweaty, I believe the second day I had a sore throat. My boss sent me to get a Covid test and that came back negative.

Immediate arm soreness after injection but otherwise felt fine until about 2130 when over about a 30 minute period onset of fever, myalgias, chills, and nausea. Called off work from my job as a flight nurse at midnight. Tried to sleep it off until about 0430 when the body aches became unbearable. Ate a few bites of yogurt and took 400mg of ibuprofen. No change in symptoms until 0530 when I took a hot shower which helped relieve some muscle pain. Took 400mg ibuprofen again at 1030 with a small snack with no change in pain or fevers. Took hot shower again which helped briefly. Nausea subsided around 1630, enough that I had a small meal of bland food and another 400mg of ibuprofen. By 1700 more tolerable myalgias and fever came down some. 2230 another 400mg dose of ibuprofen, fitful night of sleep waking again at 4am with shooting lower back pain and fever. Took another dose of 400mg ibuprofen and a hot shower. Woke up at 1000am sweaty with mild myalgias and low grade fever. Took another dose of ibuprofen 400mg, 30 minutes later profusely sweaty but afebrile. Fatigued all day and poor appetite until late evening. Woke up next day after better night of sleep at 0730. Mild fatigue and bad heartburn all day and night. Left arm still sore to touch. This morning (1/11) feeling mild heartburn but better.

myalgias; Headache; nausea; chills; This is a spontaneous report from a non-contactable healthcare professional, the patient. A 28-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), lot number: EH9899, intramuscularly on 17Dec2020 at 10:30 (at the age of 28-years-old) as a single dose for COVID-19 immunization. The patient's medical history was not reported. The patient was not pregnant at the time of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included ethinylestradiol/ferrous fumarate/norethisterone acetate (LO LOESTRIN FE) from an unspecified date, for an unspecified indication. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 17Dec2020 at 16:30, the patient experienced headache, nausea, chills, myalgias. The patient was not treated for the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the headache, nausea, chills, myalgias was resolved on an unspecified date in 2020. No follow-up attempts are possible. No further information is expected.

12 hours from injection fatigue started. 14 hours past and chills and sweats started (highest measured temp 99.4F orally). Body aches occurred at 16 hours. Body aches and sweats and chills continued until hour 36. At hour 33 awoke from sleep with nausea but did not have emesis. At 48 hours all symptoms basically resolved.

Fever with temperature of 102.4F; Chills; Body aches; sore joints; Vomiting; The patient received the second dose 19 days from the first dose; This is a spontaneous report from a contactable nurse (patient). A 28-year-old non-pregnant female patient received bnt162b2 (BNT162B2 reported as Covid 19 vaccine), first dose intramuscular right arm on 17Dec2020 17:30 [05:30 PM](Ej1685; expiration date: unknown) at a single dose and second dose intramuscular right arm on 05Jan2021 17:30 [05:30 PM] (lot number: EK9231; expiration date: unknown) at a single dose for covid-19 vaccination. The patient's medical history was not reported. Concomitant medication included birth control medication. The patient has not received any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with covid-19 prior to vaccination. The patient experienced fever with temperature of 102.4F, chills, body aches, sore joints and vomiting on 06Jan2021 01:00. The patient received the second dose on 05Jan2021 17:30 which was 19 days from the first dose. The patient did not received treatment for the adverse event. The patient has not tested for COVID-19 since the vaccination. The reporter assessed the events as non-serious. The outcome of the events was not recovered.

Nausea; Swollen lymph nodes; tired all day; did not feel like herself-like she had the flu; soreness; This is a spontaneous report from a contactable nurse, the patient. A 28-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3246), intramuscular in the right arm on 02Jan2021 at 11:45 as a single dose for COVID-19 immunization. Medical history included polycystic ovarian syndrome, prehypertension, prediabetic, and vitamin D deficiency. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously took amoxicillin (MANUFACTURER UNKNOWN), erythromycin (MANUFACTURER UNKNOWN), and ciprofloxacin (CIPRO); all for unspecified indications from unknown dates to unknown dates and experienced drug allergy. On 02Jan2021 at 18:00, the patient started having soreness. On 03Jan2021 at 16:45, the patient had nausea. On 03Jan2021, she also had swollen lymph nodes, was tired all day, and "she just did not feel like herself-like she had the flu". The patient was not given any treatment for the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcomes of the soreness, nausea, swollen lymph nodes, tiredness, and "she did not feel like herself-like she had the flu" were recovering.

after receiving vaccine ee c/o nausea and headache. B/p 157/84 HR 95 02 sat 98% DD EE left clinic stating she would follow up with her PCP nausea resolved continue to have h/a 4/10 scale unchanged. b/p 146/73 HR 82 and 02 sat 96% EE refused RRT or ED evaluation

Headache, nausea, body aches, chills, temperature 99F starting around 6pm on the day of vaccination (I received the vaccine at 7:30am). This lasted all night and was resolved by 1pm the following day.

Systemic: dizziness,lump in throat, difficulty swallowing, numbness of lip area; symptoms lasted 0 days

dizziness; nausea; joint pain; itching and broke out in rash around injection site; itching and broke out in rash around injection site; pain and stinging on injection site location; heat and redness as well as a raised rash; heat and redness as well as a raised rash; Both ears got, rot and itchy, stomach itchy; Both ears got, rot and itchy, stomach itchy; fever of 100.7; sever heart burn; severe body aches; head ache; raised rash; This is a spontaneous report from a contactable other Health Care Professional (HCP) who is the patient. A 28-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number unknown, expiration date unknown) via an unspecified route of administration on 04Jan2021 at 10:00 AM (at the age of 28-years-old) at an unspecified dose in the right arm for COVID-19 vaccination. Medical history included removal of a metastatic carcinoid tumor from an unknown date and unknown if ongoing. The patient's allergies include minor hive breakouts from "several things." The patient's historical vaccinations included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number unknown) via an unspecified route of administration on 17-DEC-2020 at 14:00 (at the age of 27-years-old) at an unspecified dose in the right arm. The patient was not pregnant at the time of this vaccination. The patient was administered the vaccine in the hospital. Prior to this vaccination, the patient was not diagnosed with COVID-19. Concomitant medication included drospirenone;ethinylestradiol;levomefolic acid (reported as "generic form of Beyaz") and acetaminophen.The patient did not receive any other vaccines within four weeks prior to the first vaccination. On 04Jan2021 at 10:00 PM the patient experienced severe body aches and head ache, through out that night. She had dizziness and nausea with increased joint pain and body aches with the head ache increasing as well. On the morning of 05Jan2021 she experienced a fever of 100.7 and body aches. On that same day in the afternoon these symptoms subsided. She also experienced severe heart burn on 05Jan2021 that did not subside with Tums. On Wednesday 06Jan2021 she was feeling much better, and she had a "normal day." At 12:00 AM on 07Jan2021 the patient started itching and broke out in a rash around the vaccination site, and pain and stinging at injection site. She also had heat and redness as well as a raised rash. Both ears got, hot and itchy, her stomach was itchy but not red or swollen, same for the right leg and foot. She took one allergy pill, and twenty minutes later was still having a bad reaction so she took another allergy pill. She stayed awake to fill out this form, and she was hoping the reaction would stop spreading. Treatment was reported as having taken Tums for the severe heart burn and the patient also took an unspecified "allergy pill" for the itching, vaccination site rash, pain and stinging, the heat, redness and raised rash, the red, hot itchy ears, and the itchy stomach. The clinical outcome of the events severe body aches and fever was reported as recovered on 05Jan2020. The clinical outcome of headache, dizziness, nausea, joint pain, heartburn, vaccination site rash, vaccination site pruritus, vaccination site pain, feeling hot, redness, itchy, ear disorder and raised rash was reported as recovering. It was also reported that since the vaccination the patient had not been tested for COVID-19. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.

severe body aches -- started at 07:50 PM 1/12/21 and remained until Tylenol was taken (7 AM 1/13/21) Fever/chills -- started at 12:30 AM 1/13/21 and remained until Tylenol was taken (7 AM 1/13/21) nausea, dizziness -- started at 6:00 AM 1/13/21 and remained until breakfast was eaten with large glass of cold water

Diarrhea; This is a spontaneous report from a non-contactable healthcare professional (patient herself). A 28-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: Ej1686, expiry date not reported), via an unspecified route of administration in the left arm on 05Jan2021 at a single dose for COVID-19 immunisation. Medical history was not reported. The patient was not pregnant. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient has not been tested for COVID-19. The patient had no allergies to medications, food, or other products. Concomitant medications included buspirone hydrochloride (BUSPAR), escitalopram oxalate (LEXAPRO), and trazodone. The patient experienced diarrhea on 06Jan2020. No therapeutic measure was taken as a result of the event. Clinical outcome of the event was not recovered. No follow-up attempts are possible. No further information is expected.

Fever 100.4, full body aches, chills, injection site soreness, weakness, dizziness, nausea, low back pain; Fever 100.4, full body aches, chills, injection site soreness, weakness, dizziness, nausea, low back pain; Fever 100.4, full body aches, chills, injection site soreness, weakness, dizziness, nausea, low back pain; Fever 100.4, full body aches, chills, injection site soreness, weakness, dizziness, nausea, low back pain; Fever 100.4, full body aches, chills, injection site soreness, weakness, dizziness, nausea, low back pain; Fever 100.4, full body aches, chills, injection site soreness, weakness, dizziness, nausea, low back pain; Fever 100.4, full body aches, chills, injection site soreness, weakness, dizziness, nausea, low back pain; Fever 100.4, full body aches, chills, injection site soreness, weakness, dizziness, nausea, low back pain; This is a spontaneous report from a contactable other-HCP (patient). A 28-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number EJ1686), via an unspecified route of administration on 07Jan2021 13:45 at single dose for covid-19 immunization. Vaccine location was left arm and it was the second dose. Patient is not pregnant. The facility type vaccine was hospital. Patient took the first dose of BNT162B2 on 17Dec2021 13:45 (lot number EK5730) at arm left for covid-19 immunization. The patient medical history was not reported. Concomitant medication included famotidine and birth control. The known allergies included Cefzil. Patient was not diagnosed with COVID-19 prior to vaccination nor tested for COVID-19 since the vaccination. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced Fever 100.4, full body aches, chills, injection site soreness, weakness, dizziness, nausea, low back pain on 08Jan2021 00:15 with outcome of recovering. Patient didn't receive treatment for the adverse events. The events were reported as non-serious.

Nausea, lightheaded, elevated BP. Went home and started having body aches, joint pain. Improved nausea.

The unexpected reaction was localized constant left chest pain. It is believed to be due to swollen lymph nodes in the pectoral area (as all other testing at the ER was normal). Also sharp pain when breathing in deeply.

Dose 1 was on 12/16/2020, 9 days after on Christmas I became violently ill with what I assumed to be a 24 hour stomach flu or food poisoning and was vomiting approximately every 15 minutes for about 3 hours. Today 1/15/2021, 9 days after my second dose of the vaccine I again became violently ill, vomiting about every 15 minutes for approximately 3-4 hours. I reported it once I noticed the coincidence.

Got vaccine at noon with no pain. Was completely fine until 1:30am then began with chills/tremors, fever, headache, nausea and 1 episode vomiting, myalgia throughout body, dizzy/lightheaded ness and extreme fatigue. The next day Jan 16 had diarrhea all morning

At hour 8, spiked fever to 103 degrees fareinheit; Also have had intense chills, aches, headache, dizziness and mild nausea with loss of appetite.; Also have had intense chills, aches, headache, dizziness and mild nausea with loss of appetite.; Also have had intense chills, aches, headache, dizziness and mild nausea with loss of appetite.; Also have had intense chills, aches, headache, dizziness and mild nausea with loss of appetite.; Approximately 6 hours after injection felt body aches and chills.; Approximately 6 hours after injection felt body aches and chills.; This is Spontaneous report from a Non-contactable Nurse. A 28-years-old female (no pregnant) patient started to receive bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL3246), intramuscular on 08Jan2021 09:00 at the second single dose at Arm Right for covid-19 immunisation. Medical history included birth control. Concomitant medication included vitamin d3 (VITAMIN D3), ethinylestradiol, norethisterone (NORTREL) for birth control, and multivitamin. The patient previously took phenergan and experienced drug hypersensitivity, the first bnt162b2 on 18Dec2020 and experienced very mildly sore arm at injection site. On 08Jan2021 received dose #2. Approximately 6 hours after injection felt body aches and chills. On 08Jan2021 17:30, spiked fever to 103 degrees Fahrenheit. Fever stayed greater then 100 degrees with spikes to 103 for over 48 hours despite usage of antipyretics and cold compresses. Also have had intense chills, aches, headache, dizziness and mild nausea with loss of appetite. No local reaction at site noted. The patient did not received treatment for other events, except for Fever. Outcome of events was recovering. No follow-up attempts are possible. No further information is expected.

I received the dose at 12:00pm Saturday and by midnight I was awoken with severe 9/10 pain to my left arm radiating up my left side of my kneck to my ear and down to the middle of my back. This follows Sunday morning with muscle aches, joint pain, headache and nausea. Continuous nausea occurs until vomiting starts sunday mid afternoon. This all continues until Tuesday morning when a Phenergan shot IM is able to be administered at urgent care where I return home and sleep for 24 hours. Tiredness and weakness continue until the morning of Saturday 16th where I wake up feeling "normal" in a sense.

1/14/21 severe chills , fever of 101.9, treated with ibuprofen throughout entire day, sweats, headache, fatigue, body aches, nausea, soreness at injection site 1/15/21 headache, fatigue, body aches, nausea, dizziness, soreness at injection site, numbness and soreness of right 5th metacarpal; took ibuprofen for headache 1/16/21 headache, dizziness, fatigue, nausea, body aches, numbness and soreness of right 5th metacarpal 1/17/21 headache, dizziness, nausea, body aches, tiredness, numbness of right 5th metacarpal; took Tylenol for headache 1/18/21 headache, dizziness, nausea, body aches, tiredness, numbness of right 5th metacarpal 1/19/21 tiredness, nausea, numbness of right 5th metacarpal

I received the second shot of the Pfizer vaccine on 1/12/21 around 11am. By 5pm I felt very tire and during the night on 1/13/21 I developed a low-grade fever. On 1/13/21 when I woke up my entire body ached, and it felt like a truck ran over me. However, by 1/14 I felt much better and it seemed that I had fully recover. On 1/15/21 I had nausea and stomach ache, which got worst over time. On 1/16/21 I also developed a diarrhea that was ongoing until 1/19/21. From 1/15 to present (1/19) I had a stomach ache and it seemed that my stomach was not able to tolerate any food. Any time that I eat, I went to the bathroom with diarrhea.

Woke up the morning after the vaccine with dizziness, nauseous, dull headache, sensitivity to light/sun. Feeling some pain at injection site and is similar to the first vaccine in the series. Has not yet taken any meds to alleviate the reactions; but will take Advil. After the first injection, patient mainly had injection site pain, but no other adverse reactions. Has not contacted doctor regarding reaction, but is not going in to work.

FEVER, PAIN OF THE LEFT SIDE OF THE STOMACH, CHILLS. TOOK TYLENOL EXTRA STRENGTH TO RELIEVE SYMPTOMS.

My daughter woke up at 2am and I started feeling like I would throw up and I sat down and blacked out and fell into our shower and hit my head and shoulder my husband had to shake me and wake me up and I also felt like I would have diarrhea- ER said it was a vasovagal event

On 12-28-2020, I felt pretty fatigued and developed a fever throughout the following day. I lost most of my appetite and had quite a bit of diarrhea for about 24 hours. I went to the ER urgent care on 12-29-2020 in the evening. I was in the ER room for that evening then I was discharged.

Alternating sweating and cold; Alternating sweating and cold; stomachache; Nausea; Fatigue; Headache; This is a spontaneous report from a non-contactable healthcare professional (reporting for herself). A 28-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular on 07Jan2021 10:45 in right arm at single dose for COVID-19 immunization. Medical history included hypothyroidism and major depression from an unknown date and unknown if ongoing. The patient had no allergies to medication, food, or other products. The patient had first dose of BNT162B2 on 18Dec2020 15:00 via intramuscular in left arm at single dose for COVID-19 immunization. Concomitant medications included levothyroxine, bupropion hydrochloride (WELLBUTRIN), "birth control" (not further specified, and escitalopram. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. On 08Jan2021, the patient experienced alternating sweating and cold, stomachache, nausea, fatigue, and headache at 1:00 AM. She was not hospitalized, and the events were reported as non-serious. Therapeutic measures taken as a result of the headache and included acetaminophen. The outcome of the events was resolving. The patient underwent lab tests and procedures which included nasal swab: negative in Nov2020. The facility where the most recent COVID-19 vaccine was administered was in the hospital. Since the vaccination, the patient has not been tested for COVID-19. The event was considered non serious as it did not result in death, was not life threatening, did not cause/prolonged hospitalization, was not disabling/Incapacitating and had no congenital anomaly/birth defect. No follow-up attempts are needed, information about lot/batch number cannot be obtained. Follow-up (14Jan2021): This is a follow-up report combining information from duplicate reports 2021013335 and 2021015838. The current and all subsequent information will be reported under manufacturer report number 2021015838. Additional information included: reaction data (alternating sweating and cold, stomachache, nausea, fatigue, and headache). No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.

Arm pain for two days. Fatigue; muscle ache; headache , nausea that day - which lasted three to four days. The day after vaccine - I had a regular scheduled appt with neurologist - she prescribed a new med - Nurtec - I have taken twice since getting the vaccine. I'm still having ongoing fatigue; headache and nausea as well. Got period and it is more heavier than usual - almost went to ER. I have had a lot of pain and cramping associated with it. Have a lot of fluid and tissue coming out now that it's stopped.

Fevers, uncontrollable shaking, chills, sweats, muscle aches, chest tightness, painful enlarged left axillary lymph node, left arm pain, fatigue, weakness, and nausea. Adverse effects started approximately 12 hours after vaccination and lasted up to 48-72 hours.

Sars-CoV-2 vaccine (pPp treatment under Emergency Use Authorization(EUA): pfizer Received COVID-19 Vaccine at 10:45 AM. After 10 minutes post administration, while being monitored began feeling nauseated and c/o some dizziness. Denies allergies or prior events with vaccination. A& O x3, pale, diaphoretic, weak radial pulse, cool w/ delayed cap refill. Preferred to sit with her head lowered rather than supine. VS noted and cool cloths provided. Stated she ate a little this AM, BP and pulse normally low for her and currently on menstrual cycle. Advised to stay additional 15 min. VS rechecked w/o change in symptoms. Agreed to lay supine, color improved and symptoms resolved. Declined calling MERT or 911 unless she had a change in her condition. Moved to sitting position, tolerated well asymptomatic. Stood became symptomatic, returned to sitting upright in chair. Continued dizziness, pale and nausea, A&O x3. Agreed to be seen in ER, departed in wheel chair with RN (Adult ER) to be evaluated. Time B/P Pulse Resp Position Notes 10:55 98/59 59 16 Sitting/Chair Pale, cool extremities, vertigo; additional monitoring 11:00 89/56 66 14 Sitting/Chair Pale, vertigo- moved to supine position 11:05 98/65 60 12 Supine Symptoms improving 11:12 103/70 76 16 Sitting Symptoms resolved 11:18 Sitting Stand, symptoms returned- changed to sitting to w/c Departed Vaccine Clinic area at 11:20 A&O x3, pale, intermittent dizziness in wheel chair to Adult ER. Charge Nurse notified.

panic attack 2 hours after vaccine; since, multiple panic attacks, with other episodes of feeling like i'm going to pass out, dizzy, nauseated, tachycardic

severe chills, fatigue, fever 100.7F, nausea; severe chills, fatigue, fever 100.7F, nausea; severe chills, fatigue, fever 100.7F, nausea; severe chills, fatigue, fever 100.7F, nausea; This is a spontaneous report from a non contactable physician reporting for herself. A 28-years-old female patient received bnt162b2 (BNT162B2) vaccine , via an unspecified route of administration on 19Dec2020 17:00 at single dose for Covid-19 immunisation . The patient medical history and concomitant medications were not reported. The patient experienced severe chills, fatigue, fever 100.7°F, nausea on an unknown date with outcome of recovering. The patient underwent lab tests and procedures which included body temperature: 100.7 Fahrenheit on an unspecified. Unspecified therapeutic measures were taken as a result of the reported events. No follow-up attempts are possible, information about lot/batch number cannot be obtained. No further information is expected.

woke up from a deep sleep with sever lower abdominal pain, pressure and cramping feel. This migrated from middle lower to site of my appendix(rt lower). any movement made it worse. It lessened with tylenol and naproxen. I went to work, then it came back, but not as bad. Associated with fever and nausea.

Patient had difficulty swallowing and dry mouth. Was given Epinephrine, Benadryl, and Fomotodine and transported from the clinic site the Emergency Room. The effects subsided after 2.5 hours, approximately 10 pm. Observed in the ER for 4 hours.

13:21 -vaccine administered 13:40-c/o HA, nausea, dizziness, "hot, sweaty," diaphoretic HR116 BP 135/80 13:45-HR 107 BP 126/74 with worsening HA, persistent nausea.

Very sore arm the following day (difficulty using and lifting) and tired. Then two days later work up with headache and nausea.

weakness; eye pain; headache/ head pain; back pain; chills; Nauseated; her arm was killing her more than a normal vaccine; She had a fever then; This is a spontaneous report from a contactable nurse. This 28-year-old female nurse (patient) reported that she received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EL3246) at single dose at left deltoid for COVID-19 immunisation on 11Jan2021 at 4:30 pm. Relevant history included contraception. Family Medical History Relevant to AE(s) was none. Concomitant drug included ongoing ethinylestradiol, etonogestrel (NUVARING) for contraception for years. The patient experienced a headache, back ache, nausea and was almost passing out. She had the first dose of the vaccine on the 11Jan2021 at 4:30 PM and was in bed around 10:00 that night. She woke up at 5:00 AM on 12Jan2021 and didn't feel great, her arm was killing her more than a normal vaccine and she was nauseated at 5:30, which was not that horrible. She took some Tylenol. Then she got to work and around 9:00 she felt like she was going to get sick. She had horrendous nausea, chills, weakness, eye pain, headache/ head pain, and back pain. Her clothes hurt because the body aches were so bad. She felt like she was going to pass out, like a vasovagal. She went to urgent care because her manager didn't think it was side effect. She went and got swabbed (result unknown), whatever. She had a fever then. They told her it was a reaction to the vaccine. Her temperature was 101.6 degrees Fahrenheit when she went to Urgent care. She would say the fever started at 12:30PM on 12Jan2021. She did not know if fever would be ongoing because she was taking fever reducer and it was working. The events weakness, eye pain, head pain, and back pain were reported as serious since medically significant. The nausea was better around 2:00PM. The outcome of event nausea, Chills was and Weakness was resolved on 12Jan2021. The outcome of events eye pain, head pain, and back pain was resolving. The outcome of event 'her arm was killing her more than a normal vaccine' was recovering. The outcome of fever was unknown. History of all previous immunization with the Pfizer vaccine considered as suspect was none. Additional Vaccines Administered on Same Date of the Pfizer Suspect was none. Prior Vaccinations (within 4 weeks) was none. AE(s) following prior vaccinations was none.; Sender's Comments: The Company cannot completely exclude the possible causality between the reported events, weakness, eye pain, head pain, and back pain, and the administration the suspect vaccine, BNT162B2. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RA, IEC, as appropriate.

Labored breathing/shortness of breath; Extreme fatigue; Resting heart rate 104 bpm; Full body myalgias; Nausea; This is a spontaneous report from a contactable pharmacist. A 28-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ1686), intramuscular at the left arm on 09Jan2021 17:00 at a single dose for COVID-19 immunization at a clinic. Medical history was reported as none. Patient has no known allergies. The patient was not pregnant. Concomitant medication included desogestrel, ethinylestradiol (VELIVET). The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899), intramuscular at the left arm on 21Dec2020 14:45. The patient experienced full body myalgias, nausea, extreme fatigue, resting heart rate 104 bpm, and labored breathing/shortness of breath on 10Jan2021, 04:30. There was treatment for the adverse events. Patient has not been tested for COVID 19 prior and post vaccination. The patient was recovering from the events.

fever of 102; chills; nausea; vomiting; headache; injection site pain; This is a spontaneous report from a non-contactable other healthcare professional (patient). A 28-year-old female patient (no pregnancy) received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3248), intramuscularly at site of left arm at 07:00 on 12Jan2021 at single dose for COVID-19 immunization. The patient's medical history was not reported. There were no concomitant medications. The patient previously took first dose of BNT162B2 (lot number: EL3248), intramuscularly at site of left arm at 7:00 AM on 22Jan2020 for COVID-19 immunization and experienced injection site pain. The patient experienced fever of 102, chills, nausea, vomiting, headache and injection site pain, all at 23:00 on 12Jan2021. Facility type vaccine was in hospital. No other vaccine received in four weeks. No other medications received in two weeks. No treatment received for adverse event. Adverse reactions did not result any serious consequences. No covid prior vaccination. No covid tested post vaccination. No known allergies. No other medical history. The outcome of events was recovering. No follow-up attempts are possible. No further information is expected.

nausea; chills; arm is swollen; This is a spontaneous report from a contactable consumer (patient). A 28-year-old female patient second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number and expiry date: not known), via an unspecified route of administration on 11Jan2021 11:30 in the left deltoid at single dose for COVID-19 immunization, administered in the hospital. Medical history included birth control. The patient's concomitant medications were not reported. The patient received first dose of BNT162B2 on 23Dec2020 administered in the left deltoid. Her arm was swollen as she noticed this morning (12Jan2021) when she woke up, about 07:00. She placed ice on it and the swelling had gone down a little. Nausea and chills started around 09:30 this morning. The outcome of the event arm was swollen was recovering; while outcome of the events nausea and chills was not recovered. Information on batch/lot number was requested.

Fever (highest at 101.8); Chills; Moderate nausea; Fatigue; Muscle aches in injection arm; This is a spontaneous report from a contactable nurse (patient). A 28-year-old female patient (non-pregnant) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EL3248), intramuscular in left arm, on 09Jan2021 at 17:30, at a single dose, for COVID-19 immunization. The patient's medical history was not reported. The patient's concomitant medication included ethinylestradiol/ ferrous fumarate/ norethisterone acetate (JUNEL FE). The patient previously took the first dose of BNT162B2 (Lot Number: EL0140) on 19Dec2020 (04:30 PM) for COVID-19 immunization (intramuscular in left arm). The patient had no known allergies. The patient was not diagnosed with COVID-19 prior to vaccination. No other vaccine was administered in four weeks. The most recent vaccine was administered in a hospital facility. On 10Jan2021 at 05:30 AM (day 1 post-dose number 2), the patient experienced fever (highest at 101.8) twice, chills, moderate nausea, fatigue, and muscle aches in injection arm. No treatment was administered for the events. Post-vaccination, the patient has not been tested for COVID-19. The patient recovered from the events in Jan2021.

My arm started to hurt , tingled and then turned into feeling very heavy as soon as injection was admitted. I suddenly became light headed and felt very abnormal. Broke out in hives on my neck and face . They took me to the ER department and by the time they wheeled me down the hall I was white , very disoriented. Couldn?t open my eyes and went from slurred speech to I couldn?t speak at all and couldn?t swallow. My throat and closed and I was having a anaphylactic reaction . They administered epi pen , pepcide and steroids. Since then I have been very weak , running a fever , tired , dizzy . Can hardly walk and I get out of breath from standing or walking .My muscles are very sore and have spams . Almost last night I went to the ER due to theses symptoms lingering. I have been unable to work since the vaccine was administered to me .

Severe chills, fever -103, nausea, chest pain (felt like I had a bubble in the center of my chest), abdominal pain, body pain all over, weakness, loss of appetite, migraine Symptoms started yesterday and still ongoing. Taking ibuprofen

Fevers, severe chills, headaches, nausea, arm pain and swelling of left arm (injection site). Fatigue

Fever (100.5); abdominal pain; aches; muscle aches; chills; This is a spontaneous report from a contactable healthcare professional who reported for herself. A 28-year-old female patient received second dose of BNT162B2 (Pfizer-BioNTech Covid-19 vaccine, lot number EL3248) via an unspecified route of administration 13:15 on 14Jan2021, at left arm, for Covid-19 immunization. The patient received first dose at left arm 03:15 PM on 22Dec2020. The patient's medical history included vertigo. The patient had no known allergies and no Covid-19 prior to vaccination. Concomitant medications included meclozine, montelukast, mometasone furoate (NASONEX), atomoxetine hydrochloride (STRATTERA), and levocetirizine dihydrochloride (XYZAL). 02:00 AM on 15Jan2021, the patient developed fever (100.5), abdominal pain, aches, muscle aches, chills. No treatment was received. The patient had not tested for Covid-19 after immunization. Outcome of the events was not resolved at the time of reporting. The reporter considered that the events were non-serious.

This is a spontaneous report from a contactable other healthcare professional (patient). A 28-year-old female patient received the first dose of bnt162b2 (COVID-19, brand: Pfizer) via an unspecified route of administration in left arm on 17Jan2021 15:30 at a single dose for COVID-19 immunization. The patient's medical history was not reported. The patient was not pregnant. The patient had no COVID prior to vaccination and was not COVID tested post vaccionation. There were no concomitant medications. No other vaccine in four weeks. The patient previously took trazodone and tramazole and experienced allergies to both. On 17Jan2021 16:00, the patient experienced severe headache and nausea. Treatment was not given to events. The patient had not recovered from the events. Information on the Lot/Batch number has been requested.

Within 24 hours after administration of 2nd dose of Pfizer-BioNTech COVID-19 Vaccine EUA, patient began experiencing tingling and numbness in hands and feet, weakness, fatigue, muscle and joint pain, chills, fever of 100.4 F, headache, and nausea, in that order developing over the next 48 hours.

high fever 102.6, severe body aches, chills,sweats, headache, neck pain,weakness, fatigue, nausea, runny nose, 48 hrs and going

Nausea, headache, joint pain, back and neck pain, pain at injection site, chills, hot flashes, eye pain when looking at light

10:30am- 2nd dose received 1:30pm -fatigued/ headache (Advil taken, symptoms subside) 6pm - fatigue/ sore arm/ headache (Tylenol, symptoms worsen) 11:30pm- chills, body/ muscle aches, clammy 1:30pm- worsening chills, worsening aches, insomnia, restless legs, panic attack 5am- nausea, aches, chills, fever (Tylenol & Zofran- helped minimally) continued lack of appetite Symptoms subside Approx 48 hrs after 2nd dose.

Had a low fever of 99.9 throughout the day, chills, severe headache, joint pain and weakness, dizziness, nausea.

Pfizer COVID-19 Vaccine EUA Event Description: Felt light headed and slight numbness in tongue and throat about 10 minutes post Covid-19 vaccine (Pfizer EL9261, exp. 5/1/21). History of vasovagal reactions. Also said numb tongue made her think of trouble swallowing. Given water, Benadryl 25mg PO, Zyrtec 10mg PO, and Famotadine 20mg PO and felt better. Heart: RRR without mrg Lungs: clear Skin: blotchy and slightly flushed in spots Throat clear No problems swallowing medications, also given Ginger Ale

Acute gastritis that began 7 hours following injection. Confirmed by hospital. Manifested as epigastric pain, headache, nausea, difficulty sleeping Ongoing as of 48 hours after the shot

Chills, joint pain, chest pain, shortness of breath, low grade fever, nausea, vomiting, headache. Recovered from COVID in 8/2020.

On 12/30 I developed neck pain, a headache, chill and shaking but no fever, diarrhea, ear pain and nasal congestion. I had a virtual visit with the NP and was advised if the symptoms got worse to take tylenol and ibprophen. I was advised I could take mucinex and recommended a COVID test. It was performed on 12/31 which was negative so I took mucinex for the congestion and after 2 or 3 days I began to feel better.

nausea vomiting and painful flush feeling in chest and extremes. improved after vomiting but nausea and flush feeling persisted for 3 hours

'Had second dose of Pfizer vaccine on 1/13 at 4:30PM. The following morning (1/14), I experienced nausea and light headedness. This resulted in fainting multiple times and be transported to via ambulance. After receiving fluids, symptoms decreased but continued to have fever/body aches until following day (1/15).'

FIrst dose was administered on 05Jan2021; Fever; Sore arm around injection site; swollen and sore lymph nodes: neck and arm of of injection; swollen and sore lymph nodes: neck and arm of of injection; Indigestion; This is a spontaneous report from a contactable 28-year-old female consumer reporting for herself A 28 years old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: El3300) on 22Jan2021 at 08:15 at single dose via an unspecified route of administration on right arm for COVID-19 immunization. Relevant medical history included Shellfish allergy and allergy to doxicicline. The patient received first dose of vaccine on 05Jan2021 at 03:00 PM on right arm, lot_number=Ej1685. On 22Jan2021 at 18:00 the patient experienced fever, sore arm around injection site, swollen and sore lymph nodes: neck and arm of injection Indigestion (as reported). At the time of the reporting the patient had not yet recovered from reported events.

fatigue; dizziness; nausea; muscle soreness; This is a spontaneous report from a contactable consumer. This 28-year-old female consumer (patient, pregnant: No) received 1st dose of BNT162B2 (COVID vaccine) on 15Jan2021 06:15 PM at single dose on Left arm for covid-19 immunization. Medical history was Herniated disc. Known allergies: Steroids and anti-itch creams (unspecific). No other vaccine in four weeks. Concomitant drug was ethinylestradiol/norgestimate (SPRINTEC), Omeprazole. Patient reported experiencing Fatigue, Dizziness, Nausea and muscle soreness for 3 days since receiving the vaccine on 15Jan2021 08:00 PM with outcome was not recovered. No treatment. No COVID prior vaccination. No COVID tested post vaccination. Information on the lot/batch number has been requested.

fatigue; slight headache; nausea; sore arm (left); swollen lymph nodes -left arm; This is a spontaneous report from a contactable consumer. A 28-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL8982), via an unspecified route of administration at arm left on 20Jan2021 at single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0142), via an unspecified route of administration at arm left on 30Dec2020 at single dose for COVID-19 immunization. On 20Jan2021, the patient experienced fatigue, slight headache, nausea, sore arm (left) and swollen lymph nodes (left arm). The patient outcome of the events was unknown.

After Dose 1 - mild headache, fatigue, arm soreness for 2 days After Dose 2 - mild headache, fatigue, arm soreness for 2 days. Appendicitis resulting in appendectomy 4 days later

Body aching, fatigue, and mild stomach ache lasting about 24 hours. Low back pain lasting about 48 hours.

In the evening had chills, shaking, could not get warm, low grade fever, 01/13/2021next day all over body aches, 99.9 and then arm pain at injection site nausea and diarrhea 01/14/2021 nausea and diarrhea disappeared on 01/14 or 01/15/2021. Nausea and diarrhea with first dose for two days.

Sore arm for 3 days, headaches same day until current, chills same day to current, dizziness same day till current, fatigue, diarrhea increased heart rate

lymph node swelling in axilla in arm of injection site started with 6 hours after vaccination. Fatigue, fever as high as 101 , chills, nausea started approx. 12 hours thereafter. Ibuprofen was used to treat systemic symptoms. Systemic symptoms resolved after 12 hours. Lymph node swelling resolved after 7 days. Patient

Client complained of feeling nauseous. Client given bucket if needed and she requested water and felt better after having some.. She waited an extra 10 minutes and left facility with friend.

6pm: body aches, feeling cold, not hungry or able to finish my dinner, drowsy. I went to bed around 7pm. All that night, I was hot and sweating and freezing cold. I had a lot of pain in my lower back and would have to position myself in fetal position. There was no position that felt comfortable. 24 hours after the shot, still fatigue, stayed in bed for most of the day. No appetite. 48 hours: limited appetite, I was hungry, but when eating just felt bloated and not interested. Would feel stomach aches if I attempted to eat more. The monday following the vaccine, I had eaten lunch and noticed I had a burning feeling in a lower area of my throat. My stomach felt slightly upset.

Chills were the first symptom. The next day, I also experienced feeling very cold and some chills. I passed out briefly after getting out of bed and threw up right after that. I had body aches. I was nauseous but was able to take ibuprofen in the late morning. After the ibuprofen wore off, my body aches returned as well as a lethargic feeling. The next morning, I experienced nausea again until in the afternoon.

1/11, 7pm: Headache, nausea 1/12, 4:30am: Body aches 1/12, 7pm: Vaginal lesions 1/13, 5am: Increase in number of vaginal lesions 1/13, 2:30pm: Seen by primary care physician, increased number of lesions, open and bloody, labs and cultures drawn, prescribed topical Lidocaine and Valacyclovir 1/13, 7pm: Lesions progressed to open ulcers 1/13, 11pm: Development of new lesion on labia majora 1/14, 5am: Increased edema and deterioration of ulcers 1/14, 7pm: Worsening edema and further deterioration of ulcers 1/15: Seen in clinic by a dermatologist, prescribed topical Clobetasol, additional blood work drawn 1/16: Started topical Clobetasol 1/22: Follow-up lab work 2/1: Ulcers started to heal 2/8: Internal ulcers nearly healed 2/10: Labia majora ulcer nearly healed

Arm was tingling; heavy; Became dizzy; Felt very weird; Broke out in rash on neck and face; Went pale; Couldn't open my eyes; Slurred speech; I couldn't breath; couldn't speak; couldn't swallow; My throat had closed up; I am still very sick and unable to work; This is a spontaneous report from a contactable other healthcare professional (patient). A 28-year-old female patient received first dose of bnt162b2 (Pfizer-BioNTech COVID-19 mRNA vaccine), via an unspecified route of administration in the left leg on 21Jan2021 14:30 at a single dose for covid-19 immunization. The patient has no medical history. The patient had not had covid prior to vaccination. patient is not pregnant. Concomitant medication included isotretinoin (ACCUTANE). On 21Jan2021 14:30, immediately after administering vaccine the patient reported arm was tingling, heavy, patient became dizzy, felt very weird, broke out in rash on neck and face, went pale, couldn't open her eyes, slurred speech, then patient couldn't breath, couldn't speak and couldn't swallow. The patient added that her throat had closed up. The patient was administered with Epi pen. The patient reported that she was still very sick and unable to work. The patient underwent a covid test post vaccination via nasal swab on 25Jan2021 and 26Jan2021 with negative result. The outcome of the events was not recovered. Information about lot/batch number has been requested.; Sender's Comments: Based on the time association and product's safety profile, the reported serious events are possibly related to suspect BNT162B2 administration. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.

Awoke around 11pm 1/28 with aches, chills, severe headache, weakness, dizziness, and nausea; Awoke around 11pm 1/28 with aches, chills, severe headache, weakness, dizziness, and nausea; Awoke around 11pm 1/28 with aches, chills, severe headache, weakness, dizziness, and nausea; Awoke around 11pm 1/28 with aches, chills, severe headache, weakness, dizziness, and nausea; Awoke around 11pm 1/28 with aches, chills, severe headache, weakness, dizziness, and nausea; Awoke around 11pm 1/28 with aches, chills, severe headache, weakness, dizziness, and nausea; could not regulate my temperature; fluctuated between being diaphoretic and cold to being overheated; fluctuated between being diaphoretic and cold to being overheated; fluctuated between being diaphoretic and cold to being overheated; I did experience an episode of nearly passing out sometime during the night; Fatigue throughout the day increased.; This is a spontaneous report from a contactable other Health Professional reported for herself. A 28-years-old female patient received dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in left arm on 28Jan2021 10:00 at single dose for COVID-19 immunization. Medical history included SLE (systemic lupus erythematosus), asthma (mild), PTSD (post-traumatic stress disorder), anxiety, ADHD (attention deficit hyperactivity disorder), allergy to egg whites, allergy to bee stings and diagnosed with COVID-19 prior to vaccination. Concomitant medication included desvenlafaxine succinate (PRISTIQ), methylphenidate, hydroxychloroquine sulfate (PLAQUENIL), clonidine received within 2 weeks. The patient previously took escitalopram oxalate (LEXAPRO) and experienced Allergy to lexapro, sertraline hydrochloride (ZOLOFT) and experienced Allergy to Zoloft, quetiapine fumarate (SEROQUEL) and experienced Allergy to seroquel, erythromycin and experienced Allergy to erythromycin. On 28Jan2021, the patient experienced fatigue throughout the day increased. The patient developed headache. Awoke around 28Jan2021 23:00 with aches, chills, severe headache, weakness, dizziness, and nausea. She did not feel she could move safely to retrieve OTC medications for these symptoms which were far worse than any illness she can recall having. She likely would have went to the ER for help but she couldn't have driven herself and her kids were home. She did not want to call 911. On 28Jan2021 23:00, she did experience an episode of nearly passing out sometime during the night when she attempted to sit up on the edge of the bed to take some Tylenol. She could not regulate her temperature as she fluctuated between being diaphoretic and cold to being overheated. In the morning she finally felt well enough to go to her medicine cabinet downstairs and decided to essentially sedate herself for the day with Benadryl, Xanax, zofran, Tylenol, and ibuprofen. She then slept from about 10am until about 5pm. She felt considerably better upon waking up, with just fatigue, nausea, and headache. The report was reported as non-serious. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not pregnant. Since the vaccination, the patient had not been tested for COVID-19. The outcome of the events fatigue, nausea and headache was not resolved and the outcome of the other events was resolving. Information on the lot/batch number has been requested

Blindness (loss of vision); Neurocardiogenic syncope; Tingling in hands and feet/lower legs; Panic attack/unable to breathe; Nausea; Vomiting; Dehydration; Tiredness; Body aches

Extreme fatigue; headache; heart was racing; nausea; diarrhea and body aches. These lasted until 06:00 AM the next day. A little headache and arm soreness still that next day - by noon that day I was feeling myself again.. I took ibuprofen for the headache and that helped.

Headache 5am, hurts to lift head or move neck; Nauseous since 1am; Chills since 1am; All over muscle aches and pains 530 am; Fever 100.4/feeling feverish 6am; Shaking/shivering since 3am

tingling and numbness in hands and feet; tingling and numbness in hands and feet; weakness; fatigue; muscle and joint pain; muscle and joint pain; chills; fever of 100.4 F; headache; nausea; This is a spontaneous report from a contactable healthcare professional (patient). A 28-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9262 and expiry date unknown), via an unspecified route of administration on 26Jan2021 18:00 at a single dose on the left arm for COVID-19 immunization. Medical history included asthma, fibromyalgia, ADHD, GERD, IBS, and allergies to pollen and yellow onions. Concomitant medications included bupropion hydrochloride (WELLBUTRIN), diltiazem, and topiramate. Patient is not pregnant at the time of vaccination. The patient received the first dose of bnt162b2 on 05Jan2021 15:00 (lot number: EL1284) on the left arm. The patient was not diagnosed with COVID-19 prior to vaccination. Patient was tested for COVID-19 post-vaccination: Tempus iC SARS-CoV-2 RT-PCR on 28Jan2021 with result negative. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 27Jan2021 14:00, within 24 hours after administration of second dose, patient began experiencing tingling and numbness in hands and feet, weakness, fatigue, muscle and joint pain, chills, fever of 100.4 F, headache, and nausea, in that order developing over the next 48 hours. Patient has not recovered from the events. Adverse events resulted in doctor or other healthcare professional office/clinic visit. Treatment received for the adverse events includes Tylenol. Events reported as non-serious.

Evening of the vaccine, Sunday, had left arm soreness, and vomited that night. I woke up Monday morning with a fever of 101.6, extreme fatigue, nausea, vomiting, aches and pains and chills. Monday went to get a COVID nasal swab test as required by my work-place, was negative. Tuesday, I had continued nausea, fatigue, chills, fever of 99-100. Went to see Healthcare Professional, they ran labs (detailed below), only found low eosinophils, and leukopenia. Received nausea medication. Was able to eat on Wednesday, severely fatigued Wednesday, temperature remained 99-100. Thursday had major fatigue, headache, nausea. Was feeling better on Friday.

Pfizer-BioNTech COVID-19 Vaccine EUA injected into left arm at 10:15 am on 17 Feb. Soreness at the injection site was the only symptom immediately following the injection. At about 3:00 am the next morning, I experienced extreme nausea and chills. I fainted when I tried to get out of bed to go to the restroom. All of 18 Feb, I experienced the following symptoms: headache/migraine, fatigue, dizziness, loss of appetite, muscle aches/soreness, fever, and severe pain in my left arm. As of today, 19 Feb, I am experiencing headache, lightheadedness, and mild pain my left arm.

Fever, chills, tiredness, headache, body aches, sore lymph nodes, and nausea started approx 10 hours after shot. Took ibuprofen and acetaminophen for the duration of the symptoms Sunday night and all day Monday. By the time I woke up Tuesday morning (approx 42 hours after shot) the only remaining symptom was sore lymph nodes and more tired than usual.

Pt stated she felt lightheaded. Denies SOB, chest pain. She stated that she did eat breakfast this morning and thought she may have been hungry and needed to eat lunch and she thought it may be indigestion. Gatorade and water given to pt and pt tolerated well. BP checked 120/80, HR 95. PT advised that if symptoms persist go to urgent care or to the closest PCP. PT verbalized understand and stated she felt fine to leave.

1/15/21 Chills a few hours later after vaccine 1/16/21 temp 99.9 despite Tylenol, nausea, shoulder, chest pain, cold sore call out sick on 1/16 and 1/17

3-5 minutes after receiving the vaccine, I felt a sense of panic and a tingling on my lips, that then spread to my mouth, throat, and tongue. I asked the nurse if my lips were swollen, and she said no. A few minutes later my heart rate increased and I felt really lightheaded. After 7-10 minutes I felt my tongue tingling and it had become swollen. I told the nurse that I think my tongue was swollen and she said it looked okay. I had a hard time talking because I wasn't used to be tongue being so large. The nurses stayed and talked to me for the rest of the 30 minute waiting period. I was able to talk and breath while making a conscious effort. I wasn't sure whether the high heart rate and lightheadedness were associated with my condition, Postural Orthostatic Tachycardia Syndrome. I kept checking my tongue to see how swollen it was. After the 30 minutes, the nurses had me stand up to see if I could. Once I could, they said I was all set to go. They did not get an Epi-pen for the swollen tongue or give me instructions on how to treat it. They were insensitive and dismissive of my symptoms. they kept repeating "I think your just nervous." Once I got home, I still had the swollen tongue and tingling, but was able to go up and down stairs and go about my day. It was a little difficult to swallow one of my pills when I got home, but I was able to. I checked my blood pressure around 4:30 p.m. and it was 121/84 and my pulse was 79 bpm sitting. I did not take anything to treat my swollen tongue. The swollen tongue and tingling feeling in my throat continued for another 2.5 hours, until 6:00 p.m. Once the swelling was down, my tongue felt like I burnt it on a hot beverage, almost a numb feeling. I also experienced more common side effects such as body aches, fatigue, and feeling feverish. After this episode I had extremely high anxiety where it was difficult for me to sleep the following night. I called a 24/7 nurse line and she said to talk to my doctor. I had less than 4 hours sleep the night after I had my vaccine. I called my doctor's office this morning and I spoke to a nurse who worked as a nurse on the COVID Vaccine hotline. She relayed the message to the doctor who was covering for my doctor while she's on medical leave. I received a call around 9:30 a.m. saying that the doctor on leave recommend I should talk to my PCP but that she thought I had an allergic reaction to the Pfizer vaccine and that I should not get the second dose. She said they were not sure how I would react with the second dose, and they're afraid that my allergic response might be more severe and life threatening. I hope this report helps other people who experience these symptoms.

Four hours after receiving my COVID vaccine second dose I had a headache. The next morning I developed a fever up to 100.8 F. I was very nauseous and fatigued. I was unable to work because of my fever. The fever lasted two days. The headache lasted five days. The nausea continued and I found out I was pregnant that Friday. I have had severe morning sickness I?m on three medications to try to help keep it at bay. I?ve lost 13lbs. But the baby is looking healthy. I am due in September.

About 12 hours after injection, I had nausea, body aches, and bad chills. These effects lasted about 7 hours.

Pfizer-BioNTech COVID-19 Vaccine: Thirty minutes after receiving vaccination developed trunk flushing, nausea, and tiredness. Flushing quickly resolved but patient reports nausea, abdominal pain, mild headache, and tremors since vaccination. Six days after vaccination noticed hip bruising in the absence of falls or trauma and a cut on the hand that bled more than expected. No respiratory distress or rash noted on exam. Vital signs all within normal ranges. Patient left clinic visit stable and advised to avoid non-steroidal anti-inflammatory medications.

Nauseousness; fatigue; diarrhea; This is a spontaneous report from a contactable consumer reported for herself. A 28-year-old female patient (non-pregnant) received first dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine; lot number and expiry date were unknown), via an unspecified route of administration on the right arm on 31Jan2021 17:30 at a single dose for COVID-19 immunization. The patient has no other medical history. The patient has no known allergies to medications, food, or other products. Since the vaccination, the patient has not been tested for COVID-19. The patient was not pregnant at the time of the vaccination. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 01Feb2021 at 08:00, the patient experienced nauseousness, fatigue, and diarrhea. No treatment was received for the reported adverse events. The outcome of the events was unknown. The case has been considered non-serious. Information on the lot number has been requested.

Zero adverse effects after first dose. Roughly 10 hours after second dose, I had some body aches, injection site soreness, and headache. I took 650mg of acetaminophen. Roughly 12 hours after the second dose I had increased body aches, injection site soreness and swelling, worsening headache, and nausea. Roughly 18 hours after the second dose, I had chills, a low grade fever, worsening body aches, worsening headache, nausea and vomiting. I took 975mg of acetaminophen. At this time, 27 hours after the second dose, I have body aches, exhaustion, and lack of appetite. I have not vomited in 6 hours and temperature is 99.3.

back of her left shoulder is very painful; soreness; weakness in left arm; horrible pain injection site; redness at the injection site for 3 days after; Stomach pain; Nausea; Headache; redness in left arm; This is a spontaneous report from a contactable consumer (patient). A 28-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EL3247), on the left arm, intramuscularly on 25Jan2021 14:00 at single dose for COVID-19 immunisation. Medical history included ongoing seasonal allergy diagnosed a couple of years ago, ongoing food allergy she has had allergies to tree nuts, peanuts, shellfish, and sesame seeds her whole life. Concomitant medications include an unspecified product. The patient previously received the first dose of BNT162B2 on 04Jan2021 at around 12:30-13:00, intramuscular injection in left arm Lot number: EL1284 for COVID-19 immunization and experienced soreness. The patient also reported to have received a flu shot on an unspecified date in 2019 and had soreness. The patient reported to have received the second dose Monday, 25Jan2021 at 14:00 and had redness in her arm which recovered completely on Thursday 28Jan2021. On Tuesday night, 26Jan2021, the patient was sick with stomach pain, nausea, and a bad headache that went away by Wednesday, 27Jan2021. She was less sore on Wednesday, 27Jan2021, and she worked out, she did yoga, she got horrible pain at the injection site which started on 28Jan2021, Thursday morning in the middle of the night and stopped by the end of the day. States it went away with pain medication. The pain is nothing like she experienced before. The vaccine site area has been a little sore. She did yoga again last night and the same thing happened, she got pain at the injection site that was horrible. Reports the back of her left shoulder is very painful, it is sharp pains that do not go away on unspecified date. Took some Tylenol for pain at the injection site and left shoulder, that didn't help, took Aleve, heat and ice and by the end of the day, patient was fine. Just some soreness until middle of the night again, same reaction as before. Reports she had redness at the injection site 3 days after on 28Jan2021. She forgot to mention that she had weakness in her left arm that started 28Jan2021 and then she was fine and the weakness started again today. The outcome of the events redness in her arm was recovered on 28Jan2021, sick with stomach pain, nausea, and a bad headache was recovered on 27Jan2021, pain at the injection site, back of her left shoulder is very painful, weakness in her left arm was not recovered, while for the rest of the events was unknown. The patient was vaccinated in a hospital.

Fever, muscle aches, chills, sweats, nausea, vomiting, fatigue, tight chest, cough, soreness in shoulder (where I got vaccinated). Nausea lasted about 4 hours, fever lasted about 6-7 hours, aches and sweats lasted about 15 hours, fatigue lasted about 40 hours, chest tightness and mild cough lasted 48 hours and sore shoulder is continuing beyond 48 hours but slowly improving with time

Est DD: 08/07/2021 Patient reported feeling hot and light headed within 5 minutes of receiving injection. Assisted into on the cot. Reports feeling shaky and anxious. States worried because of being pregnant, nausea as well. 1240 BP 147/89 HR Spo2 99% 1245 BP 126/86 HR 104 Spo2 100% 1255 BP 142/87 HR 96 Spo2 99% ( edge of bed) 1305 All symptoms have subsided. Standing on side of bed. 1310 No further issues . Accompanied out by family member.

Patient received her 2nd dose of Pfizer Covid-19 vaccine, Lot #EN6199, in her left deltoid on 3/11/2021 at approximately 9:24am. Patient disclosed to nurse and medic at vaccination clinic that she had allergies to peanuts and eggs and would need to wait in the parking lot longer than usual. Nurse and medic confirmed this and advised she wait a minimum of 30 mins but longer if she felt necessary. While waiting in the parking lot, at approximately 10:25am, patient began to have shortness of breath and made the medics aware. Patient also had facial redness and nausea. Medics administered 50mg of Benadryl , 0.3ml Epinephrine, and started IV with IV fluids. Patient was transported to Medical Center.

Shortly after receiving the shot at work, I developed worsening dizziness as well as a headache and internal tremors, which resolved. I later developed generalized itching, worse on the back of my hands and feet, which resolved. The following day, I developed palpitations while at rest and mild shortness of breath. I also had a brief bout of nausea, which resolved, but I still have palpitations and mild shortness of breath.

Nausea - patient feeling nervous after vaccine. After getting fresh air, patient condition improved. Patient refused transport. Medical assessment findings within normal limits.

Client stated that she had prior history of vaso-vagal response to vaccinations, finger pricks and blood draws, that usually they have her lay down when she gets shots. She also has had nausea and dizziness after other shots. She felt nauseous within 2 minutes and was pale and faint, weak. Checked her bp was between 100/60 and 120/80 pulses 40-60. she was"passing out" between answering questions, called EMS and asked her about what she had eaten this morning. she stated some of a bagel but not all. F/U on 3/12 states she felt better with normal BP/pulse while in ambulance and the EMS released her with out transfer, she sat in her vehicle for 1 hour before driving home. she felt weak with sore shoulder on 3/11

Nausea, exhaustion, lightheaded/ dizziness, sore arm around injection site, light headache. lots of rest and hydration. symptoms lasted for 48 hours, only beginning the morning following the injection, (sore arm began right away).

Symptoms: Fainting, Unconciouness (repeatedly), Profusive Sweating, Low Blood Pressure (60 over unknown number), Nausea, Dizziness, Unable to stabilize quickly, not able to get an IV, extreme thirst Signs: Immediately felt unwell within 5 minutes of the vaccine. Time Course: Injection (1st dose - Pfizer) at 4:00pm. Adverse Reaction at 4:05/4:10 (est.) Released at 5:00pm (est.) Description of Incident: On March 8th, at 4:00 pm, I received my first dose of the covid vaccine. Within 5 to 7 minutes, I felt unwell while sitting in the waiting area. I walked towards a worker to inform them that I was feeling unwell and that I was going to pass out. I became unresponsive and laid on the ground. My husband was with me at the time. I was unconscious for a bit and when I regained consciousness, my legs were being raised. I regained consciousness and was able to recall my name, DOB, and address. After I was done recalling my information, I began to lose consciousness again. They brought a wheelchair and took me to the medical room. As I moved from the wheelchair to the bed, I began to lose consciousness again. They told me to lay down. I overheard a woman ask my husband if I had diabetes or heart problems. He answered ?No.?. She explained to him that my body did not know how to accept the vaccine and was trying to regulate back to normal. She explained that my body was going through ?homeostasis? (?). While I laid on the bed, some workers took my blood pressure and tried to start an IV. One of them made a comment and said I was extremely dehydrated. This was odd to hear because I normally drink 3 to 4 liters of water daily. During this entire medical event, I felt the water pushing out through my pores. I was drenched in sweat. He tried to start an IV on my left arm and was unsuccessful. He tried to start an IV on my right hand, which was also unsuccessful. He stated they were unable to start IV liquids because my veins kept popping/collapsing. My blood pressure was reading 60. They checked it again, still at 60. I laid in the bed and basically waited it out. After a few minutes, they checked my blood pressure at it was at 120. They said that was good and I was good to go. No report was given to me nor my husband about the event that occurred. Even after they agreed to let me use a wheelchair (due to feeling weak), one was not provided to me. They basically stated that I was ?good to go?, after doing a series of hand squeezes and walking a few steps upright. I am currently trying to obtain a copy of the report I saw the gentleman fill out at the time. I was given Zofran to help with my nausea, it was placed under my tongue. After going home, I felt weak, tired and somewhat lightheaded. My husband drove me home and I got some rest. I set an appointment with my doctor on Friday March 12th to determine what happened to me during my vaccine and to record the incident. After describing the incident, she determined that it was anaphylaxis. She recommended for me not to get my second dose due to the anaphylactic shock I experienced with the first dose. She was shocked to learn that they did not transport me to the hospital or provided an Epi Pen injection. When asked why I didn?t drive myself to the hospital, I let her know that they told me I was ?good?. They did not explain what had occurred to me, no mention of anaphylaxis was explained. I was not aware that is what had occurred. The incident occurred from 4:00pm (injection time) to 5:00pm (left location).

Patient started complaining of difficulty breathing, difficulty swallowing and nausea. Wheezing noted, epi administered. Patient stated that her symptoms improved following epi. EMS called and patient transferred to the hospital.

Lightheadedness, nausea (no vomiting), anxious. She has a history of anxiety with needle injections. She laid down on the floor (voluntary, no syncope, no mental status changes), when taken to private section of the Center via EMS stretcher. Symptoms lasted 20 minutes, then resolved on their own.

Nausea, vomiting and bodyaches. Employee states her Left arm is swollen from injection site down to her hand. Arm is very painful to move.

Pt had chest pressure and slight pain starting 10 minutes after the injection. Patient then had worsening chest pressure and pain, slight nausea, dizziness, palpitations, and left upper extremity paresthesia which lasted a few minutes. The symptoms resolved but hen recurred later when she was in the post-vaccine monitoring area. Pt also felt pre-syncopal and was then sent to the emergency department. Her symptoms resolved shortly thereafter but she had an additional episode while waiting in the ED. She reports she currently feels some chest pressure and LUE burning. No exacerbating or alleviating factors. Not associated with shortness of breath.

11 pm pm 3/17: Developed chills and minor headache. Nausea. Took 600mg ibuprofen. 11:30 PM: developed low fever and body aches. Nausea, 5/10. 1:00 AM: Fever ~101, severe chills 2:30 AM: severe body aches and joint pain 3:00 AM: 103* fever. Chills. 3:30 AM: took 600mg ibuprofen. 6:00 AM: Sweats with 100.5-101* fever. 6-11 AM: Sweats continued. 12:00 PM: sweats and body aches subsided. Nausea and headache 1-2/10 severity. Ate. 2:30 PM: body aches and chills restarted. Nausea increased. 600mg ibuprofen. 3:45 PM: Body aches and joint ache increased in severity.

Vomiting lasting 18 hours, diarrhea lasting 36 hours, unable to keep down liquids or food, fatigue, large swelling in left armpit, body aches

1/14 vaccination. Later that evening, into 1/15, I woke up and I was sweating. Took temp; 100.6. Chills. HA. I went back to sleep, woke up to very bad HA. I took prescribed meds for HA. Achy, nauseated. 1/15 afternoon, I contacted Neurologist. Took the fioricet didn't work. Took the 230-3pm, I took Ketorolac on advising from Neurologist. 1/18 Neurologist sent over the Norco script; 1/20 went to see Neurologist. HA was gone. But still not feeling 100%. Dr. did want 2nd vaccine due to my job and exposure is high risk. 2 days before 2nd vaccine Neurologist advised to take Frovatriptan 2.5 mg. HA only lasted 2 days. *COVID + 11/11/2020

At 4:15 pm, While under observation for 30 minutes, pt c/o heaviness in the eyes., and slight chest pain. pt. also c/o nausea and vomiting symptoms. pt. c/o numbness in the left arm. Pt. was encouraged to take deep breaths. Pt. was helped to the ground in a supine position. BP=140/90, HR=88, RR=18 . Pt was alert and oriented X4. 2 minutes after deep breaths, patient reported that all symptoms had subsided except numbness in the left arm.

Pain at injection site, severe stomach pain and dieherria 12 hours after injection for about one hour

4am started to get chills. 6am extreme nausea and dizziness along with the chills. Extreme fatigue began shortly after. Nausea and dizziness subsided around 12. Aches, chills and fatigue lasted until about 8am the next day.

815am - notice entire left arm is swollen and red, a few minutes later extreme nausea, dizziness, chills, which lasted about 20 minutes. Fatigue and aches followed which slowly faded and were gone by about 4pm

I started having body aches and chills at about 9:30pm, I took 500mg Tylenol as I had a fever temp of 100.4. as the night progressed fever continued to climb to temp 102.5 and I started to get nausea. When I took a second round of Tylenol at 2:00am, I vomited 30 min later. Couldn?t keep water or Tylenol down until 4:00am when my fever was temp 101.2

Generalized Tonic-Clonic Seizure; feeling unwell; slightly nauseous; still a little slow in speech and gait; still a little slow in speech and gait; This is a spontaneous report from a contactable consumer (patient). A 28-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6202), via an unspecified route of administration, administered in arm right on 05Mar2021 08:00 as a single dose (at the age of 28-years-old) for Covid-19 immunisation. The patient was not pregnant at the time of vaccination. Medical history included epilepsy, hypopituitarism, central diabetes insipidus, neoplasm of brain, irregular menses, short-term memory loss, elevated LDL, and myopia w/ astigmatism. The patient had known allergies to surgical tape and contrast dyes. Concomitant medications included desmopressin acetate (DDAVP), lamotrigine (LAMICTAL), levetiracetam, and zonisamide; all were taken for an unspecified indication, start and stop date were not reported. The patient previously took amoxicillin and experienced drug allergy. On 08Mar2021 at 06:15 PM, the patient experienced generalized tonic-clonic seizure, feeling unwell, slightly nauseous, still a little slow in speech and gait. Therapeutic measures were taken as a result of generalized tonic-clonic seizure, feeling unwell, slightly nauseous, still a little slow in speech and gait as Nayzilam 5 mg two doses was administered. Clinical course details as reported: the patient finished dinner and evening medications before 6 pm and started feeling unwell and slightly nauseous soon after. Laid on sofa, started to sit up at 6:20 pm, and went into a Generalized Tonic-Clonic Seizure. The patient's father administered Nayzilam 5 mg (2 doses); seizure ended and the patient went into a deep sleep until 8:00 pm. The patient was largely recovered, but still a little slow in speech and gait. The outcome of the events was recovering as reported. Information on the lot/batch number has been requested.

Lightheaded, dizzy, 1 episode clear emesis, Semi-fowlers position, rested, nausea, subsided, refused transport, felt better

12 hours post vaccine: Developed fatigue, nausea, chills, body aches. No fever recorded. Injection site felt hot and swollen but did not appear swollen. 18 hours post vaccine: Took 1000 mg tylenol and went back to sleep 20 hours post vaccine: Woke up feeling better, went to work 24 hours post vaccine: Developed bad headache, fatigue and nausea again 30 hours post vaccine: Took 1000 mg tylenol and 500 mg ibuprofen 32 hours post vaccine: Almost all symptoms gone, only mild residual injection site soreness still present

Dizzyness, nausea, flushed, tingling in the legs. VR reported typical reaction to all vaccines minus leg tingling.

13 weeks 6 days at time of injection, 14 weeks 0days at onset of symptoms. Body aches and chills started at 1am. Vomiting started at 2am and last until 4p. Was unable to keep food or liquids down during that period. Had highest fever of 100.7 F, as well as nausea, body aches, chills, fatigue and severe pain at injection site. Nausea and fatigue continued into day 2 after getting vaccine (3/27).

Fever 100.4, 3/26/21 9am, 6pm, 10pm Severe headache (7 of 10 on pain scale) 3/26/21 All day Nausea 3/26/21 9pm Body aches 3/26/21 All day

My left hand in the pinkie finger and ring finger are numb ,as well as my right hand is sore and hard to grip very painful, my throat glands are swollen, today I went to pass a bale movement and much strain so I removed it only to discover blood in it. I'm very worried about these health issues that have never been experienced,. March28,2021 Sunday morning bale pass blood seen and noticed around 9:30 am.

Patient reports sudden onset of severe nausea, sweating. C/o "not feeling well and feeling hot". Patient was assessed by onsite clinic EMS, vitals were taken and evaluated. Patient was monitored for 30 additional minutes. Patient's symptoms resolved, never vomitted. Patient disposition: went home and recovered feeling fine.

acute appendicitis; abdominal pain; profuse vomiting; This is a spontaneous report from a contactable nurse (mother). A 28-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), intramuscularly, on 22Mar2021 (at the age of 28-years-old) as a single dose for COVID-19 immunisation. Medical history included mild reactive airway, seasonal allergies, and mild eczema. The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications, taken within two weeks of vaccination, included unspecified birth control pills. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), intramuscularly, for COVID-19 immunisation and experienced no problems. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient experienced acute appendicitis, abdominal pain, and profuse vomiting on 24Mar2021. The events caused hospitalization from 24Mar2021 to an unspecified date. The clinical course was reported as follows: In the early morning hours of 24Mar2021, the patient developed severe abdominal pain and profuse vomiting, and went to the emergency room (ER). A computerised tomogram (CT) scan revealed acute appendicitis on 24Mar2021, and she had an appendectomy the same day. At the time of reporting, the patient was currently in the hospital but was reported to may be discharged home later that day (24Mar2021). The patient underwent lab tests and procedures which included COVID-19 test: unknown results on 24Mar2021. Therapeutic measures were taken as a result of all of the events as aforementioned. The clinical outcome of acute appendicitis, abdominal pain, and profuse vomiting was not recovered. The batch/lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.; Sender's Comments: Based on the information currently available, the events acute appendicitis abdominal pain, and profuse vomiting most likely represent intercurrent medical conditions and are unrelated to Bnt162b2 vaccine. Case will be re-assessed upon the additional information provided. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.

Swelling my eyes significantly; Having my tongue go somewhat numb; Difficult to swallow; Feeling worse; Some feverish feelings; Hives all over my body, especially on my face; Chills; Couldn't stop shaking; This is a spontaneous report from a contactable consumer (patient, self-reported). A 28-year-old female patient (who was not pregnant at the time of vaccination), received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: ER8732 and expiry date was not provided), via an unspecified route of administration, in arm left, on 26Mar2021, at 14:00 as single dose for COVID-19 immunisation. Patient medical history was not reported. She did not have any known allergies. Concomitant medications included estradiol valerate, progesterone and cyanocobalamin (VITAMIN B12). Patient stated that she first experienced some feverish feelings, chills and hives 30 minutes following her vaccination. She drove home from the hospital and was feeling a bit off, but mostly okay. By the time she got back, she was feeling worse, around 4 PM. By 5 PM she had broken out in hives all over her body, especially on her face, swelling her eyes significantly and having her tongue go somewhat numb, starting to make it difficult to swallow. She also had significant chills, and couldn't stop shaking, and ended up being admitted to the ER. After being given antihistamines, the swelling went down and eventually the chills stopped after monitoring in the hospital. The patient was hospitalized for the events on an unknown date in Mar2021. Treatment received for the events. The patient was not diagnosed with COVID prior vaccination. The patient had not been tested for COVID post vaccination. The patient did not receive any other vaccine in four weeks of vaccination. Outcome of the events was recovered on an unknown date in Mar2021.

This is a spontaneous report from a contactable consumer (patient). A 28-year-old female patient (not pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 01Apr2021 11:15 AM (Lot Number: ER8737) as SINGLE DOSE for covid-19 immunisation. Historical bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 04Mar2021 12:15 PM (Lot Number: EN6199) as SINGLE DOSE for covid-19 immunisation. Medical history included migraine, irritable bowel syndrome (IBS), attention deficit hyperactivity disorder (ADHD). No covid prior vaccination, no known allergies and no covid tested post vaccination. The patient's concomitant medications included unspecified drug and not enough space. There is no other vaccine in four weeks. Patient experienced adverse events on 02Apr2021 included Arm Pain right after 02:00 AM, Headache around 2am, Nausea around 2:15am, Fainted around 2:20am, Weak Legs around 2:30am, Tingling in hand & feet around 2:30am, ringing in ear around 2:30am, Light fever around 7am, Headache persisting until just now after getting some sleep finally from 12pm-2pm now.AE resulted in Doctor or other healthcare professional office/clinic visit. There was unknown treatment were received for adverse events. The outcome of headache was not recovered. The outcome of other events was recovering.

This is a spontaneous report from a contactable other health professional (patient) reported that a 28-year-old female patient (not pregnant) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot number and expiration date not provided), via an unspecified route of administration, in left arm, on 30Mar2021 12:00 (at the age of 28-year-old, not pregnant), at single dose, for COVID-19 immunization. Medical history asthma, heart palpitations, and MTHFR gene mutation. Patient had no COVID prior vaccination. Patient had no known allergies. Concomitant medications included lisdexamfetamine mesilate (VYVANSE), ethinylestradiol, norgestimate (SPRINTEC); ascorbic acid (VITAMIN C); ergocalciferol (VITAMIN D), and multivita. The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot number and expiration date not provided), via an unspecified route of administration, in left arm, on 09Mar2021 17:00 (at the age of 28-year-old), at single dose, for COVID-19 immunization. The patient experienced feeling like passing out and severe lightheaded, feeling like throwing up, on 31Mar2021 and 12:00 and were serious. On 31Mar2021, at 12:00 to 3:30, patient had severe nausea, severe dizziness, severe lightheaded, feeling like throwing up, feeling like passing out, heart pounding, heart rate 130, abdominal pain and cramps. At 3:30 to 5:30, patient had extreme chills, lightheaded, heart pounding (not as bad), heart rate 125-130, headache, body aches and stiffness. At 5:30 to 8:00, patient had lower back pain, body aches stiffness, headache/head pounding, heat flashes, patient's temperature was 100 degrees F, and heart rate was 130. At 8:00, patient's temperature was 98-99 degrees F. On 31Mar2021 all day, patient had body aches, lower back pain, mild headache, nausea, and lack of appetite. No COVID tested post vaccination. Therapeutic measures were taken as a result of events and included treatment with paracetamol (TYLENOL). The outcome of the events was recovering. Information on the lot/batch number has been requested.; Sender's Comments: Based on temporal association a contributory role of BNT162B2 to the reported events cannot be excluded. Case will be reassessed if additional information is received. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.

Appendicitis the following Sunday requiring surgery; This is a spontaneous report from a contactable consumer (patient). A 28-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration, administered in left arm on 01Apr2021 15:30 (Batch/Lot number was not reported) at the age of 28 years old, as single dose for COVID-19 immunisation. Medical history included COVID-19 from an unknown date and unknown if ongoing. The patient was not pregnant at the time of vaccination. The patient has no known allergies. The patient's concomitant medications were none. No other medicines received within two weeks of vaccination. No other vaccines within 4 weeks prior to vaccination. The patient experienced appendicitis the following Sunday (18Apr2021 00:00) requiring surgery. The event resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care, hospitalization, life threatening illness (immediate risk of death from the event). Treatment was surgery. It was unknown if the patient has been tested for COVID post vaccination. The patient was recovering from the event. Information on the lot/batch number has been requested.

fainted; dizzy; warm; arms had seized up and were twitching; leg and body had also briefly been shaking; eyes were dilated; vomiting; arm is sore; sweaty; This is a spontaneous report from a non-contactable consumer (patient). A 28-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 18Apr2021 11:00 (Batch/Lot Number: Unknown) as SINGLE DOSE for COVID-19 immunisation. The patient was not pregnant at time of vaccination Medical history was reported as none. There were no concomitant medications. The patient previously had first dose of BNT162B2 (Lot number: ER8727) on 28Mar2021 01:00 PM in the left arm at 28 years old for COVID-19 immunisation and experienced fainted. On 18Apr2021 11:15 AM, the patient fainted about 10 minutes after second dose was vaccinated. The patient became dizzy and very warm and then woke up about 5-7 seconds after had fainted. The patient's arms had seized up and were twitching and leg and body had also briefly been shaking. The patient was very sweaty and warm. The patient's eyes were dilated when woke up according to the overseeing nurse. The patient said it was scary. Half hour after, the patient felt fine but then began vomiting when got home. The patient's arm is sore but nothing else has happened. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was recovering. No treatment was given to the patient for the events. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

injection site soreness; general body aches; upset stomach; This is a spontaneous report from a contactable consumer (patient's guardian). A 28-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: unknown), via an unspecified route of administration on 07Apr2021 at 16:15 at single dose for COVID-19 immunization. The patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: unknown), via an unspecified route of administration on 17Mar2021 at 04:15 PM at single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient was not allergic to medications, food, or other products. The patient received other medications the patient received within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 07Apr2021 at 19:00, the patient experienced injection site soreness, general body, aches, upset stomach. No treatment was received for the adverse events. The outcome of the events was recovering. No follow-up attempts are possible; information about lot/batch number cannot be obtained

Abdominal pain; Headaches; This is a spontaneous report from a contactable consumer (patient). A 28-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration, administered in left arm on 08Apr2021 08:15 (Batch/Lot number was not reported) at the age of 28 years old, as single dose for COVID-19 immunisation. Medical history included acid reflux, asthma, allergy to peanut butter, allergy to dogs, and COVID-19 (COVID-19 prior to vaccination: Yes). The patient was not pregnant at the time of vaccination. The patient took unspecified other medications in two weeks. No other vaccines received in four weeks. On unspecified date the patient experienced abdominal pain (hospitalization) and headaches (hospitalization). No treatment was given for the events. The events resulted in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care visit. The patient has not recovered from the events. The patient has not been tested for COVID-19 post vaccination. Information on about lot/batch number has been requested.

On and off neuropathy in hands and feet; Right ear sensitivity / "popping", like with changing air pressure,; Slight woozy/dizziness; Injection site soreness; tingly outside of left arm / left pinky; Very mild headache; tiredness; Stiff / sore neck (including upper shoulder area) Left side of left arm and leg including hand; sore neck (including upper shoulder area) Left side of left arm and leg including hand; sore neck (including upper shoulder area) Left side of left arm and leg including hand; slight numbness/ Slight numbness in pinky fingers on both hands, and left toes; General "not feeling good"; nausea; This is a spontaneous report from a contactable consumer (patient). A 28-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), at same age, via an unspecified route of administration, administered in Arm Left on 06Apr2021 10:45 (Batch/Lot Number: EW0162) as single dose for covid-19 immunisation. Medical history included developmental trauma disorder, drug allergy, allergies certain adhesives, borderline personality disorder, and irritable bowel syndrome. Patient is not pregnant at time of vaccination. The patient's concomitant medications were not reported. The patient experienced very mild headache, and mild tiredness were on 06Apr2021. On 07Apr2021 (day 2), patient was experienced injection site soreness, tingly outside of left arm/ left pinky. During day 6-7 (in Apr2021), patient experienced headache, stiff / sore neck (including upper shoulder area) left side of left arm and leg including hand and foot, tingly and slight numbness, general "not feeling good", slight nausea/ need to lie down, but not fatigue / wooziness. No fever. On 13Apr2021 (day 8), patient experienced slight woozy/dizziness, in waves. Slight numbness in pinky fingers on both hands, and left toes. On 14Apr2021 (day 9), on and off neuropathy in hands and feet, specifically left leg from knee down (outside of left toes and bottom of left foot) and pinky fingers, most notably when falling asleep/ waking up, or after being on my feet for a while. Right ear sensitivity/ "popping", like with changing air pressure, but on and off (most likely unrelated, but during same period). Adverse event result in doctor or other healthcare professional office/clinic visit. No treatment for events. The patient underwent lab tests and procedures which included saliva test: negative on 13Apr2021. The outcomes of events were unknown.

Immediate tingling to face, then on 12/23 migraines and smell adversions, 12/24 chills body aches and skin burned, 12/25 no taste or smell with chills body aches diarrhea skin burned and brain fog, 12/26 positive rapid covid test and symptoms continue

Experienced nausea and dizziness. Lost consciousness in elevator. Blood pressure and heart rate dropped. Husband was present and took me to the ED, where I regained consciousness gradually. Received treatment.

developed a migraine; nausea; sensitivity to light and sound; sensitivity to light and sound; she developed significant loss of mental clarity (brain fog); On 18Dec in the AM, developed progressive severe soreness at injection site, worse than any other vaccine, hurt even just the the touch. This lasted about a total of 36 hours and progressively improve; brain fog; retroorbital headache/intermittent mild tension type frontal headache; This is a spontaneous report from a contactable physician (patient). A 29-year-old female patient received first dose BNT162B2 (lot number EH9899), via an unspecified route of administration on 17Dec2020 12:00 at 29 years old at single dose at Left arm for COVID-19 immunization. Medical history included Mirena IUD, personal and family history of retinal migraines (without headache). The concomitant medications were magnesium citrate, melatonin, ademetionine (SAME) and fish oil. On 18Dec2020 in the AM, developed progressive severe soreness at injection site, worse than any other vaccine, hurt even just the touch. This lasted about a total of 36 hours and progressively improved. There was no swelling, redness, or other local symptoms. In the afternoon on 18Dec2020, she developed significant loss of mental clarity (brain fog) while at work. In the evening on 18Dec2020, developed mild retroorbital headache (this was actually the first headache of my life). All day 19Dec2020 and about half the day of 20Dec2020 developed a migraine (also the first of my life), experienced as retroorbital pounding headache, sensitivity to light and sound in 19Dec2020, nausea without vomiting in 19Dec2020, and loss of mental clarity. She had intermittent mild tension type frontal headache on 20Dec2020 PM with all other symptoms resolved, all symptoms resolved by 21Dec2020 AM. The patient used naproxen 440 mg and Tylenol 1000 mg on 19Dec2020. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient was not Allergic to medications, food, or other products. The outcome of the events was recovered on 21Dec2020. The information on the batch number has been requested.; Sender's Comments: Based on information available, the reported loss of mental clarity together with other events was likely related to the first dose BNT162B2 due to temporal relationship and clinical course. The case will be reassessed should additional information become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.

Mild nausea (dizziness, tightness in jaw, sour taste in mouth, stomach pain) 5-10 minutes after injection. Muscle soreness at injection site beginning in the evening.

Sudden onset of tachycardia and palpitations; Sudden onset of tachycardia and palpitations; tachypnea without SOB; Sudden elevation of BP 178/100; Dizziness; Nausea; skin tingling; This is a spontaneous report from a contactable other healthcare professional, who is also the patient. A 29-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number: EJ1685), via an unspecified route of administration in the left arm on 30Dec2020 at 12:30 (at the age of 29-years-old) as a single dose for COVID-19 vaccination. Medical history included Psoriasis, psoriatic arthritis, exercise induced asthma (no inhalers or treatment for >10 years). The patient had known allergies to methotrexate and chlorhexidine. The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient's concomitant medications received within 2 weeks of the vaccination included apremilast (OTEZLA) 30mg BID (twice a day), bupropion hydrochloride (WELLBUTRIN XL) 300 QD (once a day), and buspirone hydrochloride (BUSPAR) 5mg. The patient had not received any other vaccine within 4 weeks prior to the vaccine. On 30Dec2020 at 12:30 the patient experienced sudden onset of tachycardia and palpitations and tachypnea without SOB within 3-5 minutes of injection. The patient also had sudden elevation of BP 178/100, dizziness, nausea, and skin tingling. The patient's BP gradually came down over 60 minutes. The dizziness lasted about 50- 60 minutes. No medication or medical assistance required. The patient was able to drive home. The patient did not receive any treatment for the events. The clinical outcome of the events was recovered. It was also reported that since the vaccination, the patient had been tested for COVID-19 on 27Dec2020, with Test: Nasal Swab and Result: Negative.

Within 10 minutes following vaccine administration, patient had vomiting, lightheadedness, weakness, and verbalized feelings of being cold along with a very flushed appearance. Skin was slightly moist and very warm to touch. Complained she felt the same as when she was diagnosed with the coronavirus infection in March of 2020. Patient continued to experience ongoing weakness in all extremities, dizziness followed by complaints of some changes in her sense of the light with her eyes closed. Shortly thereafter patient began complaining of her heart "speeding" up. Medic arrived and transported patient to the local emergency room. On 1-2-2021 patient provided additional information including that later on the evening of the adverse event the arm where the injection was given became painful and itchy. Patient stated the pain and itching extended into Friday 1-1-2021 and then on into Saturday, 1-2-2021 she developed a sore throat, and some difficulty swallowing (described it as feeling something "stuck" in her throat) along with hoarseness. The patient also verbalized she remained weak, with a very sore arm and some small blisters which had formed on the same arm as where the injection had been given. A couple of the blisters the patient described where on the thumb of her hand as well her arm.

1/4/21 12 hr after vaccine fever of 101.3 bodyache and chills . On 01/05 Joint pain ,chest pain hot sweat chills and diarrhea

Experienced minor chills about 11 hours post vaccination (7:00pm) and took 1000mg acetaminophen and went to bed at 9:30pm. Woke at 11:30pm with uncontrollable chills, nausea, headache and muscle spasms (shaking). Took 1000mg acetaminophen and was able to get back to bed at 2:30am. Had a vivid/stressful dream ongoing off and on all night about completing a task I couldn?t understand, was irrational, and completion would lead to the symptoms subsiding. Woke back up at 4:00am with chills and shakes and a headache and took another dose of acetaminophen. Relaxed at 5:00am and got out of bed. Took 600mg ibuprofen for significantly sore injection site that feels very deep and even goes into the arm pit.

Fatigue; Nausea; Headache; Abdominal pain; Muscle soreness (spot of injection, it is better now); This is a spontaneous report from a contactable other healthcare professional, the patient. A 29-year-old female received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: EL0140), via an unspecified route of administration on 28Dec2020 at 04:00 PM (at the age of 29-years-old) as a single dose in the left arm for COVID-19 vaccination. The patient had no relevant medical history. The patient did not have any allergies to medications, food, or other products. The patient was not pregnant at the time of vaccination. Prior to the vaccination, it was unknown if the patient was diagnosed with COVID-19. The patient's concomitant medications in the past two weeks included bupropion hydrochloride ER 200 mg and ritual vitamins. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. On 29Dec2020, the patient experienced fatigue, nausea, headache, abdominal pain and muscle soreness (spot of injection is better now). The patient did not receive any treatment for the events. The clinical outcome of fatigue, nausea, headache, abdominal pain and muscle soreness was recovering. It was also reported that since the vaccination, the patient had not been tested for COVID-19.

5 hours after injection patient had sudden onset difficulty speaking, nausea and vomiting, and sore throat

Fever to 101.4F, headache, nuchal ridigity, tachycardia low 100s, nausea, muscle aches, extremely sore arm with injection site.

Joint pain; loss of balance; increased drowsiness; Headaches induced by allergies; Limited neck mobility/lessened neck pain but still limited mobility; Scalp tenderness and sensitivity; Significant migraines/debilitating migraines (light & noise sensitivity, covers whole head, pulsating, sharp pain, loss of balance, increased drowsiness); Sharp pains in neck/Neck pain; Sharp pains in neck, ear, head pain (similar to an ear infection pain); head pain/sharp pains in lower head/covers whole head, pulsating, sharp pain/Increase in headaches but no longer centralized to back of head/ headaches induced by allergies; Nausea; Neck stiffness; This is a spontaneous report from a contactable Other Health Professional (patient). A 29-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Solution for injection, lot number was unknown, via an unspecified route of administration in the right arm on 22Dec2020 07:30 at a single dose for COVID-19 immunization. Medical history was none. There were no concomitant medications. The patient was not pregnant. The patient had not receive any other vaccines within 4 weeks prior to the COVID vaccine. It was reported that the patient received vaccine in Tuesday (22Dec2020). The following Sunday (27Dec2020) at 12:00, she had nausea and neck stiffness. On Monday (28Dec2020), she had sharp pains in neck, ear, head pain (similar to an ear infection pain), and nausea. She used teledmed appt and got antibiotics (unspecified). On Tuesday (29Dec2020), she had significant migraines, limited neck mobility, sharp pains in neck and lower head, scalp tenderness and sensitivity which felt like whiplash when she moved her head w/ her head feeling "swimmy". She tried to see urgent care but was to go to ER. On Wednesday (30Dec2020), there was lessened neck pain but still limited mobility, increased in headaches but no longer centralized to back of head. She went to ER and they said that she had headaches induced by allergies. She mentioned that she never had migraines or allergies in her life. They also reported no ear infection. She did complete CT Scan with no concerning results on 30Dec2020. On Thursday (31Dec2020) & Friday, she no longer has neck pain but with continued nausea, joint pain, debilitating migraines (light & noise sensitivity, covers whole head, pulsating, sharp pain, loss of balance, increased drowsiness). The events were reported as non-serious. The treatment received for the adverse events included fluids, pain & nausea meds. The patient was not diagnosed with Covid prior to vaccination. She was tested for covid post vaccination on 30Dec2020 through a nasal swab with negative result. The outcome of the events neck stiffness, ear pain, scalp tenderness and sensitivity, and 'Headaches induced by allergies' was unknown; while neck pain was recovered on 31Dec2020. The outcome of the events 'significant migraines/debilitating migraines', nausea, limited neck mobility, head pain/Headache, joint pain, loss of balance, and increased drowsiness was not recovered. Information on the lot/batch number has been requested.; Sender's Comments: A causal association between BNT162B2 and the event migraine cannot be excluded based on a compatible temporal relation between vaccination and onset of event. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.

29-year-old previously healthy female presenting today with difficulty sleeping, sore throat, and nausea after receiving the second Pfizer COVID-19 vaccine around 10 AM. Patient says that after her first dose of the vaccine she had mild sore throat and hoarse voice that resolved spontaneously. She had her vaccine around 10, several hours later before coming to the emergency department between 2--230 she had the sudden onset of difficulty speaking with associated sore throat and nausea. She has had dry heaving but no large amounts of vomiting. She has not had stridor, wheezing, shortness of breath, syncope, or the development of a rash or hives. She has not had a reaction to her prior vaccines she does not have any other allergies in general. She has otherwise been well recently without infectious symptoms including fevers, chills, cough, and has not been exposed to Covid to her knowledge. Medications administered in ED included diphenhydramine 50 mg IV once, dexamethasone 10 mg IV once, famotidine 40 mg IV once, ondansetron 4 mg IV once. Had brief episode of shaking and R arm rigidity in the ED. Patient denies LOC during the episode, did not have a post ictal state, no tongue biting or episodes of incontinence. Given single event without LOC, less concern about episode being a seizure. Patient has had no further episodes of shaking since admission. CT brain was wnl, no FNDs noted on exam.

Headache and nausea with vomiting; Headache and nausea with vomiting; Headache and nausea with vomiting; This is a spontaneous report from a contactable Other HCP (patient). A 29-year-old female patient received the first dose of BNT162B2 (Lot number and expiry date not reported), intramuscular on 30Dec2020 07:15 at single dose in the left arm for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient was not diagnosed with COVID-19 prior to vaccination and since the vaccination, the patient has not been tested for COVID-19. The patient was not pregnant at the time of vaccination. On 01Jan2021, the patient experienced headache and nausea with vomiting. No treatment received for all the events. The outcome of the events was recovered on an unspecified date. The following information on the lot/batch number has been requested.

Mild nausea shortly after injection; Injection site soreness beginning in the afternoon of that day, continuing for days; Fatigue; This is a spontaneous report from a non-contactable other HCP. A 29-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 04Jan2021 12:30 at single dose for COVID-19 immunization. Medical history included endometriosis. There were no concomitant medications. The patient experienced Mild nausea shortly after injection. Injection site soreness beginning in the afternoon of that day, continuing for days and Fatigue on 04Jan2021 12:45. Patient has not been diagnosed with COVID-19 prior to vaccination. Patient has not tested for coronavirus disease (COVID-19) since having the vaccine. Outcome of events was recovered. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

Patient described Rash and itching approximately 2.5 hr after she received the pfizer covid -19 vaccine first dose. She received 1 dose of Diphenhydramine 25mg po. Few minutes later she complained difficulty sallowing and given Epinephrine 0.3mg IM and EMT was called in. She was transported to ER by EMTs

Dizziness, NauseaVomiting, Vertigo Narrative: Employee observed for 15 min in clinic after Vaccination. Went back to work, as Clinical Pharmacist. Found she felt dizzy, vertigo, and nauseated. Unable to concentrate or focus on her work. She went home to recover

Severe body aches, chills, mild nausea, malaise? I took 3 ibuprofen and 1 extra strength Tylenol to alleviate symptoms, and went to sleep around 2pm, woke up for dinner and a shower and went back to sleep through the night

Around 4 am. Fever of 100.2 and chills that lasted about 12 hours. Headache that was unrelieved by medication that lasted 24 hours. Fatigue that lasted 24 hours. Severe injection site pain that lasted 12 hours. Nausea that lasted about 12 hours.

Heart burn (severe) unrelieved by tums or pepcid x 3 nights and 3 days Fatigue Malaise Generalized muscle pain and fatigue Mild nausea

Muscle spasms and pain (pins and needles sensation), extreme fatigue, headache, debilitating body aches for 24+ hours, abdominal pain for 2 hours.

Twelve hours afterwards I had full-body convulsive-like shivers and ran a high temperature roughly 36 hours. The morning after I also had nausea and a few episodes of vomiting. 48 hours post-dose I had diarrhea

About 15 minutes after vaccine, hr 155, fever 102, covered in hives, sick to her stomach and a pounding headache. Has had headache since then and been extremely fatigue.

Body aches, chills, sweats, fatigue, tachycardia, GI (gas, diarrhea), elevated temperature (Normal 97.1 -> 99.4) lasted for about 12 hours

Fever, Tmax 101.2, lasting 48 hours. Chills; severe fatigue, still present (it has been over 48 hours). Abdominal pain, still present *for over 48 hours now). Nausea - starting after 24 hours of taking the vaccine and lasted 12 hours.

First vaccine dose received 12/18/2020 @ 1844. Symptoms appeared 1 days later. Flu like symptoms without fever, upset stomach, nausea, cough, chills, headache and general malaise. Improved with Theraflu and Tylenol .Symptoms worsened on 12/24/2020 around 1800. Runny nose, cough, headache, chills, body ache but still no fever.

Soreness at injection site began a few hours after administration. By the evening I began experiencing headache and an overall malaise feeling. This progressed into chills to the point of shivering and feeling feverish. Overnight I developed another headache and felt very mildly nauseous in addition to feeling fever/chills. Overnight I took 3 OTC Advil, was bundled up under multiple blankets, and got lots of rest. The next day I felt much better, only some fatigue.

1/8/21 - 15 minutes after second dose of COVID19 vaccine I had flushing (warm rash like) all over my chest and neck that lasted for about an hour. No itching or hives. 1/9/21 at 3am my heart rate started to increase to about 110bpm while sleeping and continued till 4am. 1/9/21 at 4am my apple watch alerted me to my heart rate was above 120bpm while resting. This is when I realized I was sweating and felt like I had a fever. I drank water and went back to sleep. 1/9/21 5am heart rate was at 135. then 6am 148bpm. 7am around 161bpm. Kept trying to go back to sleep. 1/9/21 8am got up and took an adult benadryl tablet and drank plenty of water. Tried to relax to lower my heart rate. 1/9/21 9am took another adult benadryl tablet and was able to get my heart rate just below 120 while sitting. Then ate breakfast and went back to bed. If heart rate was not going to lower, I was planning on going to the ER. 1/9/21 10am till next day. Heart rate was then under 100bpm. I was then so tired that I slept all day and did not eat anything else. 1/10 I experienced severe body aches, chills and headache. This was all day. 1/11 I woke up feeling mildly nauseous for about 3 hours and then dizzy for about an hour. after that I just had a sore arm. 1/12 Had a mildly sore arm.

During the first few hours following vaccination, I had soreness at the injection sight and a mild headache. About 10hours later, I started to experience more severe symptoms including a fever of 101-102deg, chills/cold sweats, a moderate headache, and body aches. This continued throughout the night and into the next day. In addition, I began to experience a burning sensation in my chest, similar to heart burn. I have consistently been taking Tylenol and recently took Tums to aide with the heartburn feeling.

Received the vaccine 11:20am, experienced expected arm soreness and fatigue for the rest of the day. Went to sleep with no issues. Woke up at 2:00am uncontrollably shaking with chills/goosebumps, sweating with shortness of breath. Extreme headache and all over body soreness also at that time. This continued in waves for the next several hours. I finally slept for a short time and woke with continued headache and muscle/joint soreness. This was accompanied by dizziness, nausea and decreased appetite. This persisted throughout the entire next day following vaccination. The day after that was slightly better and the subsequent day I felt relatively back to normal. I checked for fever many times throughout the symptoms but was always afebrile.

This is a spontaneous report from a contactable nurse. A 29-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), intramuscular from 17Dec2020 07:00 at single dose at right arm for COVID-19 immunization. The patient's medical history was not reported. There were no concomitant medications. On 17Dec2020 18:00, it was reported that the patient experienced fever, chills, aches, HA, stomach pains for first two nights, and only at night. Woke up, fine by morning. The events were assessed as non-serious. The patient did not receive treatment for the events. The outcome of the events was recovered. Information on the lot/batch number has been requested.

body feels like a furnace; shaking from her core; All main muscle groups sore/tense; All main muscle groups sore/tense; mild chills; arm hurts so bad, like deep in her arm pit bad; Shooting headache; Vivid stressful dreams; Nauseous; This is a spontaneous report from a non-contactable pharmacist. A 29-year-old female received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231), via an unspecified route of administration at the right arm on 05Jan2021 08:45 at a single dose for COVID-19 immunization at a hospital. The patient's medical history and concomitant medications were not reported. The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ1685) on 17Dec2020 16:45, at the right arm for COVID-19 immunization. On 05Jan2021, the patient experienced mild chills at 19:00 and took acetaminophen (TYLENOL) and went to bed, at 23:30, patient reported shaking from her core and all main muscle groups sore/tense. In addition, patient stated her arm hurts so bad, like deep in her arm pit bad, had shooting headache, vivid stressful dreams, & was nauseous on the same day of 05Jan2021. On 06Jan2021 04:00, the patient also stated her body feels like a furnace. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not tested for it since the vaccination. The patient was recovering from the events. No follow up attempts are possible. No further information is expected.

After first dose: moderate right deltoid soreness only After second dose: fever, chills, nausea for about 36 hours from onset time listed, significant headache and fatigue for 48 hours from onset time listed

Chills, 01:00 am 102 temperate and head ache and chills. Next day had head ache and fatigue diarrhea for 36 hours and got tested for 12/28/2020 Tested for COVID -19 was negative.

Fever, Chills, Severe headache and unilateral left sided neck pain, severe malaise, fatigue, body aches, diarrhea and abdominal cramps

The vaccine was given at 12:20 pm 1/9/21 8:30 pm Diahrrea 9:30 pm Exhaustion, body aches, headahce 9:30 pm-7:30 am body aches/muscle aches/joint pain so severe unable to sleep without waking up every hour 7:30 am took Ibuprofen and slept until 3 pm, exhaustion, headache 1/11/21 fever of 100.1 and body aches, headache and exhaustion, took Ibuprofen 1/12/21 back to normal functioning no aches/pains/fever

Tossed and Turned had chills awoke at 01:00 am tempt check 102. head aches, diarrhea, fatigue . Fatigue and head aches for 36 hours Tested for COVID -19 negative.

Weakness, tiredness, increase in temperature, nausea, headache, joint pain, stomach ache, heartburn, vaccination site soreness

fever (102.6F), nausea/vomiting, body aches, headache; worst at 18hrs after receiving 2nd dose, resolved roughly 24hrs after onset

1 week history of significantly worsened (previously present "low back strain" lower back pain that had become radicular to both LE and associated with progressively worsening bilateral LE weakness, paresthesias since COVID vaccination last week. see continuation for HPI and assessment/plan from office note 1/13/21 HPI from OV dated 1/13/21 She had presented initially in December 2020 for her annual physical, and we evaluated some low back pain that that time, felt to be a sprain/strain resulting from a fall in the shower earlier December which was aggravated significantly by lifting/transferring a patient at the SNF she works for as a nurse. Presentation at that time was rather benign, no imaging obtained, pt was placed on leave from work for 1 week to avoid the heavy lifting and likely aggravation of back pain, and rx including diclofenac and cyclobenzaprine. She did not FU in the office, but returned to work at SNF a week after I saw her for the back pain. She states she had improved enough to feel like she could go back to work but wasn't 100% without back pain yet. At no time was comp mentioned at the visit in December. She did tell her employer about the injury and was off of work for a week and was encouraged to seek comp. We were never notified. Yesterday 1/12 she followed up in the office for the back pain and was found to have much more severe pain, now radicular to both LE (pain intensity worse on right), with new neurologic impairment including objective weakness bilateral LE (R>L), sensation disturbance bilateral LE (R>L). Xray of lumbar spine obtained in clinic, this was essentially unremarkable, non-acute. Pt was sent for stat MRI of the lumbar spine. MRI last night revealed no findings to explain her severe symptoms - she has mild symmetric disc bulging at L5-S1 nd mild bilateral facet arthropathy with patent canal and foramina, and a mild nonspecific "STIR signal abnormality" within the soft tissues abutting the left lateral aspect of the L5 spinous processes felt to be small and nonspecific. I did discuss the case and the imaging with the radiologist and he feels this is unlikely to be the source of her back pain/radicular symptoms. No obvious signs of apparent discitis or any signficant soft tissue abnormality. Pt contacted last night with initial "normal" results of MRI as formal results were pending - hydrocodone was sent to her pharmacy for pain relief overnight. Pt received 60mg toradol in the office yesterday during her visit. Pt noted significant improvement in her back pain, bilateral leg pain about 30 minuts after that injection. She continued to have pain in the evening but went to sleep. She woke at 3am unable to roll over due to weakness and pain - her sister gave her a hydrocodone and she went back to sleep' she woke this morning feeling much better; today, she has less severe low back pain, less severe right lower leg radicular pain, NO pain radiating into the left LE, lessening of the weakness in her right LE, lessening of paresthesia reported in the right LE (now isolated just to the heel), resolution of the weakness in the left LE, resolution of the tingling of the left knee. Other than the toradol and one dose of hydrocodone, no other medications were given, no other treatments given since presentation yesterday. Upon further questioning, patient does reveal that she received the 1st of 2 COVID-19 vaccinations (pfizer) last week. She received the vaccination at work at nursing home on 1/7/21. She had some relatively quick onset nausea and dizziness within an hour of the injection, but that resolved. She recalls feeling like her low back pain, bilateral lower leg pain, leg weakness and paresthesias all intensified sometime either Wednesday 1/6/21 or 1/7/21, but more obviously worsened over the weekend 1/9 and 1/10. Along with the lower extremity symptoms, she does admit today that she experienced soreness in bilateral upper arms starting the day following the vaccine administration, with left arm/shoulder still feeling sore and tender to the touch now. She also developed some altered sensation of the right thumb and index fingers the day following vaccination (1/8/21) and this has been persistent/unchanged. She is right handed. No prior issues with right hand/fingers. Other than the altered sensation, she denies pain, swelling, or notable weakness. She is right handed, and really hasn't done much with her right hand over the past week since she hasn't been working. Patient denies having significant headache, fever, chills, diaphoresis, fatigue, rashes/injection site erythema since the covid vaccination. She was not told to sign up for or told about the V-safe program and hadn't thought to report her symptoms to work or think to be concerned regarding possible vaccine SE. Pt denies prior hx of low back pain, neurologic symptoms including weakness/paresthesias, previous allergy to or adverse reaction to vaccination or injectable medications. She has a history of latent TB(fully treated) but is otherwise in good health. After gathering much further detailed information/history today from patient, review of chart including the MRI results and xray results from yesterday, my prior OV note, and discussion with radiologist today regarding her MRI - I Discussed with patient and her sister that I believe what is becoming more apparent to me now is that she is likely suffering from an adverse event associated with the COVID-19 vaccination she received on 1/7/21 through her workplace. I'm unable to define this for certain, but I suspect that she developed the progressive worsening of low back pain, development of radicular pain and bilateral LE weakness and paresthesias about 1-2 days following the vaccination administration. She has had notable and rather surprising improvement in both subjective and objective findings Today as compared to yesterday. Only intervention was toradol 60mg IM and one dose of hydrocodone, she had already been taking diclofenac or ibuprofen so I believe the only explanation for the improvement over the past 24 hours is the fact that she is gradually having resolution of the temporary paraparesis, neuralgia, paresthesia brought on by the recent COVID-19 vaccination. I believe she truly had injury to the low back in December, initial injury at home but had improvmenet and then significant worsening/exacerbation when transferring a resident at work. Her presentation following that was consistent with a strain/sprain of the lumbar spine. This was treated appropriately with rest, activity modification, stretching, NSAID, and muscle relaxers. She returned to work w/o restriction likely earlier than she should have but I believe the covid vaccination is likely what caused her condition to so significantly decline; Its also possible that her physically demanding job requiring lifting/transferring/standing for prolonged periods of time on top of an only partially resolved low back strain had aggravated her low back condition. plan from OV dated 1/13/21 Given the improvement since yesterday, I recommended obtaining some labs looking for any sign of alternative explanation including infectious etiology or autoimmune/inflammatory condition, however will hold on further imaging as would be the plan, specifically EMG of the bilateral LEs. Explained to patient that I'm hopeful with continued rest and time, her symptoms (weakness, tingling/numbness, radicular back pain) will completely resolve. She may need some eventual PT for the disc bulge in the lumbar spine and lumbar strain that is likely still lingering. Will contact pt with any change in care plan based on the laboratory findings. I would like to closely follow her, and make sure her symptoms continue to slowly improve /resolve. If at any point she develops worsening symptoms again or any new neurologic signs/symptoms (and we discussed what emergency signs/symptoms would be) then she needs to be in touch with me right away. I will work on reporting this suspected adverse covid vaccine reaction to VAERS / possibly also CDC and see if they have any additional input/suggestions for monitoring/treatment. For pain control, pt may continue with the diclofenac OR ibuprofen, and the hydrococone/APAP as needed for breakthrough severe pain uncontrolled with the NSAID. I have advised pt to remain off of work at this time, resting at home avoiding lots of physical activity as she continues to heal. Suspect will have her follow up in clinic sometime next week for repeat evaluation/examination depending on VAERS/CDC recommendations and of course the lab results and any updated condition reports from the patient in the interim. Will want to make sure she has full resolution of the paresis and adequate resolution of her back pain/radicular pain prior to returning to work, even in a limited capacity. I am informed today that there is light duty available and will keep that in mind. Pt to be contacted regarding follow up. Encouraged to call with questions/concerns/updates. Pt was very thankful for the care.

About 12 hours after receiving the second dose of the COVID 19 Vaccine (1/9/21), I had sudden onset of fever, chills, nausea, headache, and fatigue. The fever, chills, nausea lasted for about 36 hours from onset, and notable headache and fatigue lasted for about 2.5- 3 days after onset of symptoms. They resolved by the evening of 1/12/2021.

Date of symptom onset ? 1/14/21? Symptoms - ? EE reports she woke up at 06:30 with body aches, mild headache and back pain. EE reports she took 400 mg motrin at 0700 and came to work. EE reports around 09:00 worsening HA and nausea. EE took her temp (99.1) and took 1000 mg Tylenol. EE advised by manager to call vaccine support line for recommendations. Last day of work and shift - ? EE currently at work Home remedies? ? see ?symptoms? for narrative Any improvement? - mild Recommendation? EE encouraged to continue to monitor her symptoms and to contact the vaccine support line for further questions or concerns. EE denies covid-19 exposure without proper PPE and denies travel. EE does not meet criteria to be COVID tested at this time. EE educated to continue to manage per TCH Illness in the Workplace Policy and to notify manager if she needs to leave work today. EE verbalized back understanding and denied further questions at this time.

I had a fever and chills at night and also a headache, I felt nauseous, vomiting and difficulty breathing. I could not sleep that night after I received my vaccine. I decided not to go the ER and slept it off I woke up much better next morning. I saw a Doctor a couple of days later because I had shortness of breathing and a high heart rate while I was at work. He just told me to take it slowly at work. No meds. I then started working part-time for some weeks and am being introduced again now to my regular scheduled.

I received my second dose of the vaccine at 03:00pm on 1/12/21. I noticed around 06:00pm that I started feeling a little tired and some pain around the injection site. I had anticipated this as I felt similar symptoms from the first dose of the vaccine. I took a nap and woke up around 09:00pm feeling some of the worst body aches I had felt in a long time. My arm that I received my vaccine in was painful and warm to the touch. I felt dehydrated as well so I drank a pedialyte, took OTC Tylenol extra strength, and laid down again. Around 07:00am on 1/13/21, I still felt achy, sweaty, and felt pain in the arm that I recieved the vaccine in. I went into my bathroom, and noticed two small red and raised areas around the injection site. I took pictures of the site, and continued to closely monitor through out the day. I ended up calling in sick to work on 1/13/21. It is now around 12:00pm on 1/14/21, and I woke up with a pounding headache, muscle aches, dehydration, nausea, and low energy. I feel like I am hungover or have the flu, and am planning on calling in sick to work again. I reported my symptoms to my staffing department at my workplace on 1/13/21 and wanted to file a report here as well.

Nausea and vomiting about 12 hours after injection. Followed by fevers, body aches, sinus headache, and fatigue for about 30 hours. Post 3 days after injection all finger tips have been cold, red, numbness, and tingling. Now post 5 days after injection finger tips have improved but still red, cold and difficult to get warm.

Severe headache; chills; nausea; inability to work for several days; bloating; abdominal pain; This is a spontaneous report from a contactable Physician (patient). A 29-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot: EH9899) via an unspecified route of administration in left arm on 20Dec2020 10:00 at single dose for COVID-19 immunisation. There was no relevant medical history, no known allergies. The patient was not allergic to medications, food, or other products. The patient received unspecified medications within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced severe headache, chills, nausea on 30Dec2020, 01:00 AM 10 days after first dose, requiring COVID-19 testing and inability to work for several days, and nausea, bloating, and abdominal pain persistent for 3 days. Adverse events resulted in doctor or other healthcare professional office/clinic visit. No treatment received for the adverse event. The patient received COVID test post vaccination via nasal Swab on 30Dec2020 with result of Negative. Events outcome was recovered. No follow-up attempts are possible. No further information is expected.

Shooting chest pains, delirium, dry mouth/throat with mild difficulty swallowing, severe weakness, severe fatigue, sweating.

chills; body aches; headache; nausea; fatigue; This is a spontaneous report from a contactable Physician, the patient. This 29-year-old female patient received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine) (Lot number: EK5730) (dose #1), via an unspecified route of administration in the right arm on 18Dec2020 at 14:30 (at the age of 29-years-old) as a single dose for COVID-19 vaccination. The patient's medical history was not reported. Concomitant medication included cetirizine hydrochloride (ZYRTEC SUMITOMO), levonorgestrel (KYLEENA), melatonin (MELATONIN), spironolactone (SPIRONOLACTONE). Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient previously took Celebrex for an unknown indication and experienced drug hypersensitivity. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient was not pregnant at the time of vaccination. On 20Dec2020 at 10:00, 44 hours after receiving the vaccine, the patient developed chills, body aches, headache, nausea and fatigue. These symptoms persisted for 5 days total. She was not febrile at any time. The adverse events resulted in a doctor or other healthcare professional/clinic visit. No therapeutic measures were taken as a result of the events. The clinical outcome of chills, body aches, headache nausea and fatigue was resolved on 25Dec2020. It was also reported that since the vaccination, the patient had been tested for COVID-19: negative on 21Dec2020 (saliva test) and negative on 22Dec2020 (nasal swab test).

Jan.13th- Diarrhea, extreme fatigue, extreme nausea, body aches, congestion, rash under eyes and on nose (itchy and burning). Jan14- extreme fatigue, nausea, loss of appetite, rash continues but no itching, light on burning, body aches, cold, could not get warm, temp stayed around 96.0-97.0 Jan 15- fatigue, nausea, extreme congestion, sweats, symptoms of a fever over night and during day. Cold sweats, shakes, cold then hot, body aches, fatigue. These happened off and on through the day. When started feeling crappy took temp and it was 99.6-99.8. When feeling cold temper drops down to 97.0 scratchy voice voice congestion, runny nose, little sore throat, when swallowing pills or hard texture foods, sometimes drinking something. Overall feeling of a cold. I think it?s important to note that I had Covid-19 in the month of November and received my first vaccine December 22nd. I had side effects after the first shot but not nearly as bad as this time. I am nurse in a doctors office if that matters at all. I am still feeling under the weather but wanted to get these down before I forgot them.

Myalgia; Chills; Nausea; Joint pain; Headache; Fatigue; This is a spontaneous report from a non-contactable pharmacist (patient herself). A 29-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0140, expiry date not reported), via an unspecified route of administration in the right arm on 06Jan2021 18:15 at a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient was not pregnant at the time of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient has not been tested for COVID-19. The patient had no allergies to medications, food, or other products. The patient previously took first dose of bnt162b2 (lot number: EL0140, expiry date not reported) in the right arm on 18Dec2020 at single dose for COVID-19 immunisation. On 07Jan2021 at 02:00, the patient experienced myalgia, chills, nausea, joint pain, headache and fatigue. No therapeutic measure was taken as a result of the events. Clinical outcome of the events was recovered on 08Jan2021 at 02:00. No follow-up attempts are possible. No further information is expected.

body aches; Nausea; vomiting; fatigue; headache; lymphadenopathy; This is a spontaneous report from a contactable physician (patient). A 29-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot/batch number: EL0142), via an unspecified route of administration on the left arm on 07Jan2021 08:00 at SINGLE DOSE for COVID-19 immunization at the hospital. Medical history included ankylosing spondylitis, migraine, anxiety, and insomnia. Concomitant medications included fluvoxamine (FLUVOXAMINE), and adalimumab (ADALIMUMAB). The patient previously received the first dose of PFIZER-BIONTECH COVID-19 VACCINE (lot/batch number: EJ1685) via unknown route of administration on the left arm on 17Dec2020 17:30 at a single dose for COVID-19 immunization. On 07Jan2021 18:00, the patient experienced Nausea, vomiting, fatigue, headache, lymphadenopathy, and body aches. Prior to vaccination the patient was not diagnosed with COVID-19 and since the vaccination, has not been tested for COVID-19. The patient did not receive any treatment for the events. The patient recovered from the events in Jan2021. No follow-up attempts are possible. No further information is expected.

on 1/12 symptoms experienced : temp99.5-99.8, Shivering Chills, chills, body aches, headache nausea , vomitingx4 and fatigue

whole right arm is in pain; have a swollen lymph node (i think?) around right clavicle area; Pain with minor touch to clavicle and upper arm (at site of injection); body/muscle aches; body/muscle aches; nausea; At 0230 on 07Jan21 I woke up shivering with a high fever; heart rate of greater than 100BPM all day on 07Jan21; This is a spontaneous report from a contactable Nurse reporting for self. A 29-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot#: El3248), via an unspecified route of administration in right arm on 06Jan2021 15:30 at single dose for covid-19 immunisation. Medical history was not reported. There were no concomitant medications. At 0230 on 07Jan2021 patient woke up shivering with a high fever. Didn't realize it was a fever until 5am when woke up more, temperature taken at that time was 100.6. Fever stayed all day until 2000, no less than 99.0 even with Tylenol and ibuprofen until that time. Also developed body/muscle aches around 1200 on 07Jan2021, and some nausea. Got sent home from work that day. On 08Jan21 patient synced my (brand withheld) and checked my heart rate for day before. Didn't know it till then, but had heart rate of greater than 100BPM all day on 07Jan2021. Highest it got was 130, my resting heart rate is usually in the 60s. Also on 08Jan2021 no more fever, but whole right arm is in pain and have a swollen lymph node around right clavicle area. Pain with minor touch to clavicle and upper arm (at site of injection). Will be going to visit a doctor to make sure it is just a swollen lymph node since it is now 09Jan08Jan2021 and it's still swollen and there's still a lot of pain to R arm. Outcome of event fever was recovered, of others was not recovered.

Difficulty swallowing, 30 minutes after vaccine was administered. Enlarged tongue, difficulty talking. Episodes lasted less than 1 minute and occured 4-5 times over 2 hours. No difficulty breathing, HR was not elevated. BP, pulse ox and temperature were normal.

Approximately 6 hours following the second dose in the two-dose Pfizer COVID-19 vaccination series, I began experiencing nausea, vomiting, moderate body aches, and headaches. I have been unable to keep down liquids (including water, gatorade, and soup broth) and solids. At this time, I have continuous vomiting, with each following the intake of food and/or beverages. Physical exam is negative for redness, swelling or rash at the injection site. Additionally, I have not appreciated any fever or signs of anaphylaxis. Following my first dose in the two-dose series, I did not experience any side effects other than the expected sore arm for 24-48 hours.

Headache (first and second day post vaccine) Sore throat (first and second day post vaccine) Fever (first and second day post vaccine) Nausea (first day post vaccine) Vomiting (first day post vaccine) Chest tightness/ difficulty breathing (beginning on second day post vaccine)

10 hours since second vaccination I had muscle aches, chills, myalgia, nausea, headache, and fatigue. This went on for.36-48 hrs. After flu like symptoms subsided,I started to get pins and needles in both feet, legs, and hands. Then twitching and muscle spasms in my legs.

Headache; Nausea; pain at the injection site; Fever; Chills; body ache; Fatigue; tingling/numbness at injection site; tingling/numbness at injection site; shoulder stiffness; altered taste; This is a spontaneous report from a contactable physician (patient). A 29-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) intramuscularly at left arm on 08Jan2021 at 11:00AM at a single dose (dose number: 2) for COVID-19 immunization. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) for COVID-19 immunization and experienced swelling at injection site, inflammation around injection site. No Known allergies (allergies to medications, food, or other products) and no other medical history. It was unknown if the patient was pregnant. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No other medications the patient received within 2 weeks of vaccination. Facility where the most recent COVID-19 vaccine was administered was at hospital. The patient experienced headache, nausea, pain at the injection site, fever/chills, body ache, fatigue, tingling/numbness at injection site, shoulder stiffness, altered taste - after 2nd dose. Events with start date on 08Jan2021 at 11:30 PM. The events were reported as non-serious. No treatment received for events. The outcome of events was not resolved. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Information about lot/batch number has been requested.

Started to have symptoms and fainted; Hit her nose and has a scar now; She blacked out; hit her nose, got the scar in the nose, …she was bleeding from that scar; hit her nose, got the scar in the nose, …she was bleeding from that scar; She started to feel unwell; Chills; Nausea; Rash in her arm; She had little red in her bumps; This is a spontaneous report from a contactable physician. A 29-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE Solution for injection, batch/lot no. and expiry date: unknown), via an unspecified route of administration on arm on unspecified date at a single dose (2nd dose) for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Physician stated, "she had no medical conditions, she was in very good you know very like standing with herself." Patient had her 1st dose of Covid vaccine on unspecified date for COVID-19 immunization. Physician (reporter) stated, "I am the parent of someone who got the COVID dose, the second dose yesterday. I am very concerned because my daughter yesterday (08Jan2021) started to have symptoms and fainted at 4:00 in the morning and hit her nose and has a scar now. She had her second dose yesterday (pending clarification), after the second dose last night she started to feel unwell, getting chills, nausea and when she got up to go to the bathroom, she fainted, she blacked out. She lives alone, she is an adult, she hit her nose, got the scar in the nose, and the bleeding wouldn't stop, she was bleeding from that scar. She told me it took two hours for bleeding to stop from that scar." When asked when the events started, Physician stated, "Last night (08Jan2021), at 4:00 am she took the shot during the day while she was at work. She said, she started to getting chills and then she was nauseated." When asked if patient was still experiencing the event, the parent reported no as patient was just resting. Also stated, "She didn't take any treatment but she said she took Tylenol." Physician further added, "I am concerned, we are going to be taking her to the urgent care now but I am concerned about what is going on with platelets and all of that because of what had happened, last night the bleeding wouldn't stop for two hours and she was alone at the night and weekends. She said, she had to lay down and then her dad is there now because he is closer, he is going to be taking care of the urgent care but I want Pfizer to know what my daughter has gone through last night after she took this second dose." Physician further added, "she is having a rash in her arm, she had little red in her bumps as well. I want her to go get checked up as soon as possible in urgent care." Patient was taking some Ibuprofen (later clarified that patient took Tylenol as treatment). She was not taking any other medication. Outcome of the events was unknown. Information Requested on Lot/ Batch number.; Sender's Comments: The reported faint was most likely due to an accident, and less likely causally related to the use of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE). The case will be reassessed should additional information become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.

Syncopal event; Nausea; Vomiting; This is a spontaneous report from a contactable nurse. A 29-year-old female received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number:EL1284), via an unspecified route of administration on the right arm on 08Jan2021 12:15 at single dose for COVID-19 immunisation. The patient medical history was not reported. Concomitant medication included influenza vaccine (INFLUENZA VACCINE) on 13Dec2020. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899) on 18Dec2021 12:15. The patient experienced syncopal event, nausea and vomiting on 09Jan2021 05:00. The patient received no treatment. The outcome of the events was recovering. No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the compatible time association, the event syncope is possibly related to suspect drug BNT162B2 administration. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.

Twelve hours after receiving vaccine patient began experiencing chills & body aches. The next morning (24 hours post-vaccine) the patient had a very bad migraine, chills, and body aches. Upon standing felt nauseous & dizzy, then saw black dots and vision went black for several minutes and fell to floor. Relative called 911 and vision had returned by the time medics arrived. Vitals were normal, except for low blood pressure. She took Advil and felt better by the evening.

AE's : Injection tenderness, fever, chills, headache, malaise, severe myalgia, lymphadenopathy, mild sore throat, occasional nausea and lightheadedness when standing for longer than 5-10 minutes at a time. Tx: none Outcome: All AE's except injection tenderness and right axial lymphadenopathy fully resolved within 48 hours.

About 12 hours after the vaccine, I started having arm pain at the site and low back pain which is very unusual for me as well as a dull headache which is not uncommon for me. Around midnight I woke up with chills, and severe arthralgias in all joints down to the toes and fingers, and deep, boring pain in my long bones and neck. My skin and fingertips felt like they were burning. I was nauseated but didn?t vomit. I was up all night because I couldn?t find a position I wasn?t in pain in. Tmax 100.3 F. Took a gram of Tylenol with improvement of symptoms. Felt better in AM but when Tylenol wore off around 9 am, had another wave of the same pain all over. Tylenol improved. Felt almost completely normal by 4 pm with the exception of some lingering low back pain (central not muscular).

Approximately 12/13 hours post-vaccine dose #2 I was woken from my sleep with severe body aches. Extremely uncomfortable, from neck to back to calves, without improvement with Tylenol or ibuprofen, causing me to be unable to sleep. Around hour 20 post-vaccine, I started to get chills. It wasn?t just feeling cold or shivering, it was full body convulsions that lasted approximately 15 minutes. I became nauseas and dizzy after that for about an hour, unable to stand or walk anywhere. The severe body aches continued, with no improvement from Tylenol or ibuprofen or heating pad. Aches resolved around hour 30 post-vaccine and the only symptom left was pain at the injection site.

Patient presented to emergency department on 1/15/2021 with nausea, vomiting, headache, and chills. Patient was given supportive care and discharged home in stable condition.

Second dose of COVID vaccine (Pfzier/BioNTech) received Friday morning around 8:00, I left work about an hour early that day due to rising nausea, migraine and fatigue. By the time I got to my car in the parking garage I had thrown up and was so dizzy that I called my boyfriend to come pick me up. When I got home I immediately laid down to take a nap. 3 hours later I woke up very sore and achy and still had a migraine. I remained in bed and later that night I spiked a fever as high as 101.8 fahrenheit. I had severe chills and the aches were so bad that my bones hurt all over and it felt like someone was stabbing me with a metal broom handle. Pain spiked to 8 on the pain scale and with the length of time I had this pain, it was one of the worst experiences of my life. The dizziness and fatigue caused me to need help to get out of bed to use the restroom. I took ibuprofen frequently and Nyquil at night to help relieve the effects without it doing little more than taking the edge off. Saturday night was the same as Friday night with no relief of symptoms. Fever remained around 100.9. Sunday night it dropped to 99.8 with chills, dizziness and fatigue still remaining but aches slightly lessening. Monday night I was still dizzy and weak but not nearly as in much pain and fever had subsided. Tuesday I started to feel more normal by the end of the night, just easily out of breath and off and on again headache.

Sharp, non-radiating chest pain at xiphoid process 10/10 pain worse with inspiration, better with exhalation, unable to lay down, lasting 1.5hours, finally resolved with tylenol and motrin. Two separate instances of this pain, one on 1/18/21 at 1600-1730, and one on 1/18/21 2230-0000. The second instance the pain was so severe, lead to nausea and one episode of emesis. Initially trialed treatment with antacids but that did nothing to improve the pain. Evaluation by MD on 1/19 at 1300 diagnosed with pleuritic pain secondary to inflammation. No prior history of this, no cardiac history, and no history of GERD. Other post vaccination symptoms included fever approx 10 hours following the vaccine, nausea, one episode of diarrhea, fatigue, body achs, dizziness, and chills, all of which resolved by 1/18 at 1100am.

fatigue; Severe fever (104.6); chills; nausea; muscle soreness; first dose of BNT162B2 on 22Dec2020, second dose on 09Jan2021; This is a spontaneous report from a contactable nurse. A 29-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL3302), via an unspecified route of administration on 09Jan2021 at 07:30 at a single dose on the right arm for COVID-19 immunization. The patient's medical history was not reported. The patient has no allergies to medications, food, or other product. There were no concomitant medications. The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL1284) on 22Dec2020 at 02:00 pm on the right arm for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. On 09Jan2021 at 20:00, the patient experienced fatigue, severe fever (104.6), chills, nausea, and muscle soreness. The patient did not receive any treatment for the reported events. Since the vaccination, the patient has not been tested for COVID-19. The patient was not pregnant at the time of vaccination. The outcome of the events was recovering.

About an hour after receiving the vaccine I began to feel a little dizzy, tired, and started to develop a headache. By the next day my headache became overwhelming and the the dizziness became so pronounced that I could not stand for more than 5 minutes at a time. I a had an intolerable headache on the entire bottom of my head that made my neck start to hurt. I felt nausea that did not improve until four days later. My joints were hurting sharply two days after the immunization and lasted two days. Most of my symptoms improved on the 13th of January, but were still lingering. About 5 days after the shot my symptoms resolved completely.

I felt q lump in my throat and tingly in hands qnd feet for a few minutes after. I then was speaking with management and felt faint and short of breath, continued to be tingly. Last night 1/19/21 I had a moment of not feeling well and my heart rate went from 60s to 120s with shortness of breath and nausea qnd tingling. This continued for about 30 minutes, I was debating going to the ED for the SOB. I then became really cold and had such bad shaking I couldn't hold anything for another 20 minutes. Today I continue to have some tingling. All of this on top of the expected side effects.

Unrelenting headache, chills, nausea, body aches, fever of 101.3F. Onset 14 hours after vaccine. Fever 20 hours after. Relieved with Tylenol and Motrin, ice packs.

5 minutes after receiving the second Pfizer COVID19 vaccine, it reportedly felt difficult to swallow, tongue felt large. Epi Pen administered and IM Benadryl. She was then transported to ER. On route, felt throat irritation, sore and a little bit of itchiness all over but no hives. She was observed in ER x 4 hours and released.

12 hour post vaccination starts shaving chills and mild myalgias. Took Tylenol with low grade temps. Overnight worsening myalgias, febrile to 101, nausea, headache despite Tylenol.

12/26 started feeling extreme fatigue and malaise then led to body aches, chills, sweats, nausea, low grade fever 99F.

First Dose- I had a headache after the shot and tremors started that even and throughout the night. No fevor. Arm very sore, going into neck. Second Dose- Felt find the night. Woke up that morning at 1am and with tremors and in a night sweat. Checked temp and it was only 96, but felt hot and was sweating. Woke up the next morning and my entire body, muscles and joints ached. My knuckles, ached, kept getting sharp pains in my knuckles. My jaw ached, difficulty eating. My entire body, my muscle ached, difficulty moving. I didn't get a headache till that evening. I also had severe heart burn that night, not sure if it was related, but I have never had heart burn that bad. The next morning when I woke up (5am) (now two days after my shot), again my joints hurts, I couldn't even stand. Its like my knees couldn't even support me and I had a massive headache. I went back to bed and woke around 9am, no longer had a headache, muscles still hurt. Around 11am, all of a sudden, muscles and joints felt fine. The only thing (day three) is my arm pit on my left side where i got the shot is bothering my extremely bad. I was able to put an ultrasound probe on my axilla area, and I have swollen lymph nodes in my axilla in the area that is very painful. I also have a dull pain in my elbow.

I woke up the morning after the vaccine and felt very nauseous with occasional lightheadedness. I was also extremely fatigued and found it difficult to get out of bed or off of the couch. I had a severe headache that lasted the majority of the day. Thursday's are typically my day off therefore I did not have to call out of work sick, however I most likely would have if I had been scheduled that day.

Pain on area of injection so bad I can?t move or use my right arm. Started around 7:30pm the day of the vaccination. Day after vaccination I have fever, nause, joint pain, chills, and the pain in the arm persists.

Pfizer-BioNTech COVID-19 Vaccine EUA fever, chills, nausea & vomiting, muscle aches, bone aches, headache - lasted about 8 hours

Severe nausea, vomiting, blood pressure changes, heart rate changes, dizziness, slurred speech. Sent to ER for monitoring and fluids.

-dilated eyes around 8 pm day of injection -extreme soreness in left arm day of injection -extreme body aches, chills, and sweats day of injection -insomnia that lasted from day of injection to early morning the next day. This was not anxiety related. -Frequent burping the night/overnight after getting injection -feeling of being hungover the day after the injection but this could be due to sleep deprivation from the insomnia.

Body aches; chills; nausea; headache; arm pain; fatigue; received second dose of BNT162B2 on 09Jan2021; This is a spontaneous report from a contactable nurse (patient). A 29-year-old female patient received second single dose of BNT162B2 (Pfizer, solution for injection, batch/lot number and exp date not reported), intramuscular (left arm) on 09Jan2021 11:00 for COVID-19 immunization. Facility type vaccine: Hospital. Medical history included migraines. The patient was not pregnant. There were no concomitant medications. No other vaccine was received in four weeks. No other medication within two weeks. The patient previously took acetylsalicylic acid (ASPIRIN) wherein patient had known allergies and anaphylaxis. The patient received the first single dose of BNT162B2 on 22Dec2020 15:00, Intramuscular (left arm). The patient received second dose of BNT162B2 on 09Jan2021 11:00. The patient experienced body aches, chills, nausea, headache, arm pain, and fatigue on 09Jan2021 21:00 (09:00 pm). The patient did not have COVID prior vaccination. Patient was not Covid tested post vaccination. Treatment for AE included paracetamol (TYLENOL) OTC every 4 hours x 24 hours. The patient recovered from the events body aches, chills, nausea, headache, arm pain, and fatigue on an unspecified date in Jan2021. Information about lot/batch number has been requested.

Severe injection site pain that began around 2 hours and went into the evening, severe in the evening and night. Light soreness continued over the next day. 3 hours after receiving the 2nd vaccine, nausea, loss of appetite and general 'unwell' feeling began. Nausea, fatigue, loss of appetite, headache continued the rest of the first day. Symptoms impacted ability to work, went home early from work. Day 2: splitting headache, migraine, sinus pressure, joint pain which began in hips then spread to elbows, ankles, knees; muscle pain began in left calf then spread to shin. Injection site soreness was not severely painful any longer, mild pain. Loss of appetite continued. Nausea decreased, and no longer present by afternoon of day 2. Fatigue, increased sleep, sinus pressure in eyes, and cold chills persisted. Day 3: Migraine was present still upon waking and continued for whole day; loss of appetite remained but improved by late afternoon on day 3. Joint and muscle pain continued for duration of day 3. Fatigue continued. Increased need for sleep most noticeable today. For the first time, ibuprofen was taken for symptoms after receiving the vaccine almost 50 hour prior. Day 4: was able to return to work for the first time. Headache continued throughout day, nausea in the evening. Day 5: Headache continued but went away. Day 6 and Day 7, mild headache.

Woke up at 0205 with fever and severe chills. Standing in bathroom, began to faint, sat down. Emesis occurred immediately after sitting down. About 2 minutes later had one loose stool. Took Tylenol. At 0800 chills, Tylenol taken. At 1200 chills, Tylenol taken. At 1800 chills resolved.

Fever; nausea; vomiting; chills; body aches; This is a spontaneous report from a contactable nurse (patient) reported that a 29-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on an unspecified date then received the second dose on the left arm on 11Jan2021 08:00 both via an unspecified route of administration at a single dose for Covid-19 immunization. The patient medical history was reported as none. The patient takes multivitamins. On 11Jan2021 19:00, the patient experienced fever, nausea, vomiting, chills and body aches. The patient did not received any treatment for all the reported events. The outcome of the events was not recovered. Information on the lot/batch number has been requested.

Pfizer-BioNTech COVID-19 Vaccine EUA Loose stools: 1/22-1/25 Sore throat: 1/25, 1/26 Feeling unwell: 1/26 Fatigue: 1/26

1/14 Thursday 8am received vaccine 10am nauseous 11am soreness starts 12pm fatigue 6pm soreness heightens, slight chills, more fatigue 7pm ear itch both sides, all ear involved even lobe and red 9pm soreness, chills, arm pain 1/15 Friday 7:30am nausea, dizziness, sinus pressure, headache, arm pain 1pm extreme fatigue, sleep for afternoon, arm pain 4pm headache intensify, arm pain 6pm both ear swelling, warmth, extreme itch 9pm lingering headache, arm pain improves 1/16 Saturday 7am ear itch and rash spread to back of neck 12pm telehealth - recommended benadryl, Rx prednisone Benadryl ineffective, rash remains 8pm- itch inside ears, red scaly ears, hot after washing, extremely scaly 1/17 Sunday 6 pills of methyl prednisone Hives moved to back of neck following the back of ear 1/18 Monday 6pills prednisone inside ear itch, ear lobes itch, skin very flaky 1/19 Tuesday Go to urgent care 6pills prednisone 1/21 Thursday Rash spreads to collarbone Go to TMC Dermatology prednisone continued 1/24 Sunday Stopped steroid under recommendation of MD Huge flare up around neck, chest, back and down to lower body Itch continues to night, lack of sleep 1/27 Wednesday Placed back on steroid (16 day course) Rash remains, itch subsided Decision to not take second dose

1/15-1/16: dry cough 1/17: dry cough, feeling as if there is something stuck in throat, chest pressure/pain, lung pain, took Albuterol (INH) once 1/18-1/20: fevers 100.5 to 101.7, started 1000mg Tylenol/every 6 hours, started motrin 800mg/every 8 hours, took Albuterol (INH) once 1/18-1/23: shortness of breath, dry cough, seen in ER on 1/19, seen in ER again on 1/21, admitted on 1/21 for observation, impending doom, nausea/dry heaving, hot feeling inside body from head to toe and feeling of loss muscle tone and control in bowels and bladder, hives, dizziness/lightheadedness, joint pain in knees and ankle, headaches and migraines, extreme weakness, chest pressure, lung pain. 1/20: one episode of diarrhea 1/21-current: facial redness on cheeks and nose, hives 1/23: started benadryl 25mg/4-6 hours, pepcid 20mg/twice a day 1/23-1/25: shortness of breath improved, continues to have headaches, extreme weakness/fatigue, nausea, chest pressure, lung pain, dry cough, joint pain, extreme dizziness 1/24: started Aleve/twice a day 1/26: started prednizone, three hours after shortness of breath returned, took Albuterol (INH) once 1/26-current: hand/feet/facial numbness

About 11-12 hrs after receiving the second covid vaccine, I woke up in the middle of the night with a bad headache and extremely nauseous. I did not experience a fever or body aches. For the next 24 hrs I had nausea and vomiting on and off. Eventually it was accompanied with chills. I haven?t spoke with anyone else yet that vomited from the vaccine, so I wanted to make sure I reported this. By early afternoon 1/22 I felt back to normal.

Migraine started 2.5 hours after receiving shot (2nd dose). Intense migraine with nausea, hand and facial tingling/ numbness, seeing spots. Went away at just about 24 hours after it started. Got the chills just before it went away, no fever. Skin sensitivity and fever set in around 26 hours in - 102. Heart rate jumped from 130-170. Improved to about 150 with Tylenol and ALOT of fluids as fever improved, remained high until fever was gone around noon the next day. Hip pain, neck pain and back pain throughout. Hip pain first 24 hours. Back pain following that.

Sxs started around 2 H post vaccination: fatigue followed by difficulty sleeping. The next day, fatigue, slight cough, stomach upset, and severe headache (before noon). After noon, nausea, diarrhea, cough, SOB, and fever (max 103); in addition to all previous Sxs. Sxs lasted through 48 H. In total, 1.5 days was missed from work. I have never felt this sick before.

fever; chills; severe headache; severe muscle and joint pain; chest tightness; mild nausea; lungs felt inflamed, making it difficult to take deep breaths; unable to sleep; severe muscle and joint pain; This is a spontaneous report from a contactable health care professional (patient). A 29-year-old female patient recived the second dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot no: EK4176) via an unspecified route of administration on 12Jan2021 at 08:45 at a single dose on the left arm for COVID-19 immunization. The patient's medical history was not reported. The patient had no known allergies. Concomitant medication included colecalciferol (VITAMIN D [COLECALCIFEROL], manufacturer unknown), vitamin B12 (manufacturer unknown), vitamin c (manufacturer unknown), melatonin (manufacturer unknown), biotin (manufacturer unknown) and elderberry [sambucus nigra] (manufacturer unknown). The patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot no: EJ1685) on 22Dec2020 at 9:00 PM on the left arm. The patient did not receive other vaccines in four weeks. The patient reported that after her second dose, she began experiencing severe side effects around 5:00 pm the same day (about 7 hours after the dose was administered). These side effects were fever, chills, severe headache, severe muscle and joint pain, chest tightness, and mild nausea. She also added a difficult symptom to describe, but her lungs felt inflamed, making it difficult to take deep breaths. These symptoms lasted for 36 hours unabated, and she was unable to sleep, go to work, eat, or go about daily activities during this time. After 36 hours, the fever, chills, headache, and nausea subsided, but the muscle and joint pain and chest tightness persisted. It has been 50 hours since her second dose and the muscle and joint pain and chest tightness still persists, although its severity is reduced and it is not preventing her from work or daily activities. The patient did not receive any treatment for all the events. The outcome of the events severe muscle and joint pain and chest tightness was not recovered while the outcome of the other events was recovering.The patient did not have COVID-19 prior to vaccination and was not tested for COVID-19 post vaccination.

Chills started around 8:30pm, uncontrollable shaking from the chills, my skin hurt. My temperature was 103.5F when I checked it at 12:30am. I removed clothing and put ice on my neck, and took tylenol and the fever came down to 102.5F in 30 min. I had a moderate headache, felt lightheaded and a little disoriented, and nauseous. The following morning and the entire next day I had a moderate to severe headache, malaise, nausea, and a low grade temp 99-99.8F.

Constant stomach pains with a continuous loop of constipation and diarrhea. High levels of pain through the left arm and around the injection site.

I experienced fever and chills approximately 14 hours after injection. 20 hours after I started experiencing nausea and vomiting. This all subsided around 34 hours post injection.

Fever, rigors, severe nausea, headache, generalized weakness, body and joint aches. These lasted 10 hours. Total 4 days of significant fatigue, joint aches, neck stiffness.

First vaccine I had slight fever/ chills. Second vaccine on 01/27/21 I woke up next day with extreme body aches and a temp of 101.1. Going into today 01/31/21, I still have elevated temp been taking Ibuprofen and Tylenol but now having dizziness, left facial pressure/pain, and nausea with neck stiffness.

Fever, Chills, severe Headache, fatigue, weakness, nausea, vomiting, back pain, mouth ulcers, UTI, body aches, muscle pain, dizziness, etc.

Because of patient's previous reaction, pt premedicated with famotidine 20 mg, benadryl 25 mg, ibuprofen 400 mg 30 min before injection. Received vaccine at 9:15 AM. She initially felt well, but about 20-30 minutes after administration began to feel dizzy. Then had nausea, vomiting, dizziness, severe headache, feeling of her body being heavy, arm pain at site of administration. Vitals were monitored/stable throughout. Pt was given Zofran 4 mg disintegrating tab at 9:50, which did not do much to relieve sx. However, at 10:35 she noted that headache was gone, although still had dizziness, arm pain. By 11:08 no longer had symptoms except for arm pain. By 11:43 still feeling back to normal except for arm pain.

Pregnant at the time of vaccination?: Yes/gestational period:6/ mother was 8 Weeks pregnant at the onset of the event; Pregnant at the time of vaccination?: Yes/gestational period:6/ mother was 8 Weeks pregnant at the onset of the event; Pregnant at the time of vaccination?: Yes/gestational period:6/ mother was 8 Weeks pregnant at the onset of the event; Nausea; Vomiting; Severe myalgias; Headache; This is a spontaneous report from a contactable physician reporting for herself. A 29-years-old female pregnant patient received the second dose of bnt162b2 (BNT162B2), lot number EL0142, via an unspecified route of administration from 18Jan2021 15:00 (at the age of 29-years-old) as a single dose in the left arm for COVID-19 vaccination. Historical vaccine included first dose of bnt162b2 (BNT162B2), lot number EL1284 in the left arm. The patient's medical history was not reported. Concomitant medication included multivitamin. The patient previously took clarithromycin(BIAXIN) and experienced Known allergies: BIAXIN. No other vaccine was given in four weeks. The patient received the vaccine at a hospital. The patient's last menstrual date was 23Nov2020. Her Delivery date is 01Sep2021. Gestational period is 6. The mother was 8 Weeks pregnant at the onset of the event. On 19Jan2021 at 03:00 the patient experienced nausea, vomiting, severe myalgias and headache. Treatment included acetaminophen (TYLENOL) and antiemetic. The clinical outcomes of the events nausea, vomiting, severe myalgias and headache was recovering. The clinical outcome of the event "Pregnant at the time of vaccination?: Yes/gestational period:6/ mother was 8 Weeks pregnant at the onset of the event" was unknown. Prior to the vaccination the patient was not diagnosed with COVID-19. Since the vaccination the patient had not been tested for COVID-19.

Site: Pain at Injection Site-Mild, Systemic: Nausea-Medium, Systemic: Vomiting-Medium, Systemic: Other- Light-headed, numbness ONLY in lower hand and wrist-Medium

cannot hold anything down her stomach/ what she did eat came back up; bad headaches; bad aches; This is a spontaneous report from a contactable consumer (patient). A 29-years-old female patient started to receive the 1st dose BNT162B2 (PFIZER-BIONTECH COVID-19, lot number: EH9899), via an unspecified route of administration at right arm muscle on 12Jan2021 in the morning about 9:30AM or 10:00AM at single dose for COVID-19 immunization. Medical history was reported as none. The patient's concomitant medications were not reported. The patient had not had a vaccine before vaccination. The patient was experiencing bad aches in Jan2021, bad headaches started 15Jan2021 about 17:30, Friday evening when she got off work and cannot hold anything down her stomach when she got up about 8:00 on 16Jan2021. What could she take to settle her stomach. She didn't each much at all, but what she did eat came back up. She was scared to eat something at the moment. She was just lost. She went to the Emergency Room on 16Jan2021, but it was a long wait so she went home. The outcome of events bad headaches and cannot hold anything down stomach was not recovered, of the other event was unknown. She wanted to know what she should take for these side effects and if the 2nd dose was optional. She wanted to know if she would feel better after the 2nd dose of the vaccine. She also wants to know if it was possible for her kids to get the virus if she was having the side effects, how long does the Pfizer-BioNTech Covid-19 Vaccine remain in the system. It was not reported as serious.

HAd trembling, heart racing, chest tingling some difficulty swallowing and swelling of the tongue. She premedicated with benadryl.

Abdominal pain, diarrhea, pain in joints, tiredness, nausea, pain in the chest, chills, nasal congestion and discomfort in the throat.

Mid to low grade fever (99.5-101) from 3 days to 2 weeks following vaccine, nausea from 3 days to ~12 days after vaccine

PMH: dx with Grave's disease in 2014, s/p thyroidectomy 2/2 thyroid cancer on 8/10/2020 (now on synthroid 150 mcg). 1/26 ED VISIT: P/w chest pain/SOB went to ED. Patient received the COVID vaccination 3 days prior (1/23). Was in NSH the morning of vaccine, then in the afternoon became tired. Then developed a H/A (frontal and right sided, that has resolved) and chills. p/w SS chest pain, radiating to the right shoulder and to the back. Worsened with deep inspiration and difficult to take a deep breath. Took tylenol at 8 pm yesterday (1/25) and advil at 1 pm yesterday (1/25). A/w DOE. Denies birth control use, n/v, abd pain, urinary symptoms, tobacco/etoh/drug use, recent travel, cough, le swelling, hx pe/dvt. Patient had imagining completed - no significant findings and discharged on percocet and ibuprofen. Patient represented to the ED on 2/2/2021: Over the last two days, patient has tender right shoulder pain radiating to neck and chest with ROM and strength limited by pain associated with nausea. Evaluate for rhabdo and myocarditis - negative. Patient seen by ortho (note unable to be obtained). 2/4 Telehealth visit: The patient reports still having a swollen lymph node under her left axillary area. She denies fever. Patient reports pain to her right shoulder. She presented to ortho who said it might be an infected cyst and attempted to drain it unsuccessfully. Patient mentions pain and tingling to her left breast. She notes right shoulder pain to the back of her neck that radiates down to her left arm. She notes a stabbing back pain and rib pain when she takes a deep breath. Patient given levofloxacin and gabapentin

a fever of 101.4; headache; fatigue; severe body aches; chills; nausea; This is a spontaneous report from a contactable other HCP (patient). A 29-year-old female patient received the second dose of bnt162b2 (lot number: EL1283), via an unspecified route of administration in left arm on 17Jan2021 15:00 at single dose for covid-19 immunization. Medical history included attention deficit hyperactivity disorder (ADHD), allergic rhinitis. Concomitant medication included dexamfetamine (DEXTROAMPHETAMINE), cetirizine, and unspecified prenatal multivitam. The patient previously received the first dose of bnt162b2 (lot number: Eh9899), via an unspecified route of administration in left arm on 30Dec2020 10:00 at single dose for covid-19 immunization. Starting 12 hours after 2nd vaccination (18Jan2021 03:00) patient developed severe body aches, chills, nausea. Within 18 hours after vaccination (18Jan2021 09:00) patient had also developed a fever of 101.4, headache, and fatigue. No treatment and pregnant. The outcome of the events was Recovering.

fever, chills, headache on the night the vaccine was given that continued to Wednesday night. The next day following the vaccine administration nausea occurred and on the following day vomiting occurred/

muscle aches; joint pain; chills; nausea; This is a spontaneous report from a contactable consumer reporting for self. A 29-years-old female patient received Dose 1 of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), Lot# EK9231, via an unspecified route of administration on 28Dec2020 12:15 (at age 29 years old), as a single dose in left arm; and Dose 2, Lot# EL3247, via an unspecified route of administration on 20Jan2021 10:15 (at age 29 years old) as a single dose, left arm for COVID-19 immunization. The patient was not pregnant at the time of vaccination. Medical history included generalised anxiety disorder, obsessive-compulsive disorder, asthma, and food allergy (citrus, berries, tropical fruits, ascorbic acid, dill, crab, tree nuts, peanuts). The patient was not diagnosed with COVID-19 prior to vaccination. Concomitant medication included escitalopram oxalate (LEXAPRO), alprazolam (XANAX), diphenhydramine hydrochloride (BENADRYL), and ibuprofen. The patient did not receive any other vaccines in the 4 weeks prior to COVID vaccination. On unspecified dates after both first and second doses, she had muscle aches, joint pain, chills, and nausea. There was no hospitalization or treatment received for the events. The events were reported as non-serious. The patient was recovering from muscle aches, joint pain, chills, and nausea. Since the vaccination, the patient has not been tested for COVID-19.

After the vaccine was administered, 5-10 minutes later I began to feel a rapid heart rate. One of the nurses came to check on me, I described to her my symptoms, and she let me know if they get worse to inform her. In the next 5 minutes, my head began to hurt, as well as, some chest pain. She checked on me again, and said to let her know if things got worse. Within the next 5-10 minutes after, I had difficulty swallowing and speaking. I raised my hand, and the nurse came over, then proceeded to get help. They then took my blood pressure and heart rate. My blood pressure was 185/103 and I believe my pulse was 156 bpm. I was still having a hard time swallowing and speaking. They proceeded to get an epi pen and the doctor on site, as well as suggested to send me over the ER/ call 911. The doctor checked my lungs, and they noticed my blood pressure and heart rate was not decreasing to a normal level. I was then put in a wheel chair and transferred to the ER. At the ER, my blood pressure and heart rate was still elevated, as well as difficulty swallowing. The doctor ordered Benadryl via IV, steroids, and the epi pen. After having a reaction to the Benadryl, the epi pen was put on hold. After about 15 minutes, I began to feel better. I was put on IV fluids and observation. I was able to leave the ER around 12 pm 2/05/21. At this time, 7:22 pm, I am feeling better with mild muscle aches, and fatigue.

Broke out into a full body itchy rash several hours after receiving vaccine. Went to emergency room for visual examination. Was determined to be a mild allergic reaction, and benadryl was administered. Was evaluated at primary care doctor after rash did not go away after 2 days. No additional treatment was administered. Rash went away after 4 days. Also, 12 hours after receiving the vaccine I had severe fatigue, chills, nausea/vomiting, and headache. Was treated at home with advil and promethazine. These symptoms went away around 36 hours after vaccine was administered.

received Pfizer covid vaccine on 1/19/2021 - started showing symptoms of appendicitis (abdominal bloating and slight pain) on 1/21/2021 and worsened until I needed to have a laparoscopic appendectomy on 1/25/2021

32 Weeks pregnant Due Date: 4/1/2021 1st child About 8 hours after I started with nausea and a little fatigue. I woke up the next morning with joint and muscle pain. That lasted a full day along with the nausea. I did take Tylenol, it didn't take it away but made it more tolerable. This lasted for about two days.

Fever of 102, stomach pains, body aches, chills--fever and aches went away--2/8 stomach pain is still lingering

29F no PMH had COVID-19 almost 1 year ago. On 2/2 received 1st shot of COVID-19 vaccine. Since then with mild headache, body aches, chill. On the morning of 2/3, with prolonged standin, felt weak, abdominal pain, pre-syncopal, grabbed a co-worker and then syncopized. Caught and did not sustain injuries. Rapid response called and she was brought here.

On 2/5/21 patient received Pzifer COVID-19 dose #2 early afternoon at workplace clinic. On 2/9/21 patient reported beginning 2/5/21 early evening she began having overall body rash and body ache that progressed over the next few days to sore/swollen throat, voice loss, nausea, intermittent fever, loss of taste and smell, headache, and diarrhea. Tested COVID-19 negative 2/9/21, still having symptoms. Stated has not seen her healthcare provider but will contact for care.

Adverse event: Blurred vision, numbness left side head to shoulder, vomiting, chills, shortness of breath, severe headache, oral mycosis swelling Treatment: Benadryl Outcome: Sent to ER by facility MD, treated and observed at hospital for 1.5 hours released no negative outcome

Chest pain radiating into the back; nausea; vomiting; diarrhea; received first dose of BNT162B2 on 04Jan2021, received second dose on 19Jan2021; This is a spontaneous report from a contactable other HCP (Parent). A 29-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number-EL3248), intramuscular on 19Jan2021 12:00 at SINGLE DOSE in Left arm for COVID-19 immunisation. The patient was not Pregnant at Time of Vaccination. Facility type vaccine was Hospital. Medical history was none. Comcomitant medications in two weeks included birth control. No other vaccine in four weeks. The patient previously received first dose of BNT162B2 (lot number- EK9231), intramuscular on 4Jan2021 10:00 at SINGLE DOSE in Left arm for COVID-19 immunisation. The patient experienced Chest pain radiating into the back, nausea, vomiting, diarrhea on 20Jan2021 05:45 AM. AEs Chest pain radiating into the back, nausea, vomiting, diarrhea Resulted in Emergency room/department or urgent care. The outcome of Chest pain radiating into the back, nausea, vomiting, diarrhea was Recovered in Jan2021, of other event was unknown. No treatment for events Chest pain radiating into the back, nausea, vomiting, diarrhea. Unknown if covid prior vaccination. No covid tested post vaccination. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

constant fluctuation of burning up; sweating profusely; having chills; headache; diarrhea; dryness of mouth; runny nose; occasional coughing; dizziness; occasional fatigue; This is a spontaneous report from a contactable consumer reporting for herself. A 29-years-old non-pregnant female patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration from 21Jan2021 09:00 (at the age of 29-years-old) at SINGLE DOSE for covid-19 immunisation. The patient medical history was not reported. Concomitant medication included spironolactone, sertraline and bupropion. Prior to vaccination the patient was not diagnosed with COVID-19. The most recent COVID-19 vaccine was administered in a hospital. On 22Jan2021 11:00, the patient experienced constant fluctuation of burning up, sweating profusely, having chills, headache, diarrhea, dryness of mouth, runny nose, occasional coughing, dizziness and occasional fatigue. No treatment was received for the events. The events were reported as non-serious. The patient underwent lab tests and procedures which included Rapid Antigen: pending on 24Jan2021. Outcome of the constant fluctuation of burning up, sweating profusely, having chills, headache, diarrhea, dryness of mouth, runny nose, occasional coughing, dizziness and occasional fatigue was not recovered. Since the vaccination, the patient been tested for COVID-19.

Chest tightness and trouble swallowing 45 minutes after vaccine. Went to the ER 2 hours into symptoms. Treated with 50mg Benadryl, 60 mg prednisone and famotadine. Discharged from hospital continuing to have difficulties swallowing.

Patient began feeling nauseous at 11:15, mild emesis. BP 124/75, p-73, No complaint of chest pain or shortness of breath, no difficulty swallowing. Patient transferred to observation hub and Epinephrine 0.3 mg given by paramedics. Vital signs monitored by paramedics and after 30 minutes, patient released to home with caregiver

Swelling,heat, and redness at injection site. Severe headache, fever of at least 101.5, chills, aches, lethargy, inappetence.

PFIZER-BIONTECH COVID-19 . Individual had nausea/vomiting, fever 101.6, fatigue and body aches x 48 hours following first dose on 1/20/21. After second dose of vaccine, reported: itching, stridor, cough, nausea, vomiting, dizziness, tachycardia, acute change in mental status, temp102.5, DBP >100, tremors for 48 hours. Did not see doctor or other healthcare provider.

Between the first and second dose (1/11/21), I had significant bruising on my body. I was also light headed from time to time with decreased appetite, anxiety and heart burn. I went in for blood work and my platelet count had dropped to 5 and I was asked to come into the ER for platelet transfusion. I also received IVIG (x1) + steroid treatment (x2) and took oral steroids 4 days after.

2/18/2021 4:30am woke up nauseous, having muscle aches from injection site in left bicep to top of head on same side, not able to think clearly ?foggy?. 1:30pm having muscle aches in both sides of neck and headache left sided

Nausea, fever, chills, aches and pains, fatigue, headache, neck ache, ear pain, swollen lymph nodes, sore arm. These symptoms lasted about 2 days total.

She developed flu like symptoms the day after receiving the vaccine, including, fever, chills, nausea, vomiting, fatigue, myalgias, rash, which have persisted for 6 days.

ended up in the ED later that day with a flare up of covid symptoms, I stated hurting all over as expected, but also got lightheaded, nauseated, sugar kept dropping, felt short of breath due to coughing, head started pounding, and got very weak.

Patient felt hot, had nausea, and passed out transiently. She woke after approximately 2-3 seconds and felt well after lying down for 1-2 minutes.

Currently pregnant (25 weeks) due June 9, 2021 - no known adverse events in the pregnancy. Injection site soreness, Vasomotor symptoms, nausea. Injection site soreness lasted 48 hours. Other symptoms lasted approximately 45 minutes.

minutes after administration, patient reports head feeling strange, so I asked her to remain seated so I can observe her prior to getting up to the observation room. Then she reports feeling nauseous and weak. I asked her what medical conditions she has and she told me she is diabetic and has kidney disease. I asked if she ate breakfast, she said she did not, only had something small before heading out in the morning. I gave her am ice pack to place on the back of her neck which helped relieve her symptoms of head feeling strange and the nausea. Once nurse arrived, we checked her pulse and blood pressure, at this time it was around 11:45 am and her pulse was low at 64 and blood pressure at 94/60, which patient states is her baseline normal blood pressure. We opened the windows so she could get some fresh air since the room was very hot and shortly after we took her pulse and blood pressure she seemed to be feeling better. By 11:50 am the ambulance arrived and paramedics asked if she would like to be taken to the hospital to get checked, she said even though she is feeling a lot better, she would prefer to go just in case.

Fatigue, nausea, vomiting. Went to ER 2 days post vaccination. Received IVF, Zofran, Discharged in stale condition.

Patient received her Covid19 vaccine at 2:35 pm . She returned to the observation area at 3:25 with complaint of nausea and severe stomach ache. She said she had just been in the restroom and tried to have a bowel movement but had severe rectal pain without a bowel movement. Vital signs were: BP=118/82; P=84, regular, R= 20, Temp= 98.3. She was alert and oriented. She vomited a moderate amount 10 minutes later (2:37pm) and stated she felt much better. No complaint of any pain. Vital signs at 3:47 pm were: BP=112/82; P= 86 regular, R=18, regular and Temp= 98.2F. She declined to call her doctor/clinic. She called her mother who came to pick her up and went home. 3/02/21 - Talked with her this morning - she had an uneventful night with no more reactions or pain. Slept well. She returned to work today. She did not call her doctor/clinic.

Approximately thirteen hours after I received my second dose of the vaccine I started having cramping in my abdomen. The cramping got increasingly worse and I started to get really bad chills. The cramping feeling turned into a stabbing pain and reached a threshold that I could no longer stand so my husband had to drive me to the ER. I have never been in so much pain. Once it the ER I received medicine for the pain and a CT scan that revealed that I had appendicitis and needed to have it removed with an appendectomy.

Dizziness since 12:30pm March 2nd, nausea, pain and soreness in left arm. Swelling down to wrist. Diarrhea 6 times since vaccination, vomiting bile, headache, chills. Feeling feverish. Headache. Took Motrin 6pm March 2nd and 9am March 3rd.

fever; chills; aches; headache; fatigue; loss of appetite; Dulled taste; patient received the first dose on 12Jan2021 and the second dose was on 29Jan2021; This is a spontaneous report from a contactable consumer (patient). A 29-year-old non-pregnant female patient received her second dose of bnt162b2 (BNT162B2 reported as PFIZER COVID-19 VACCINE; lot number: El9362; expiration date: unknown) at vaccination age of 29-year-old via an unspecified route of administration in the left arm on 29Jan2021 16:45 at a single dose for covid-19 immunization. Medical history included hypothyroidism, PCOS (polycystic ovarian syndrome) and penicillin allergy. The patient was not diagnosed with COVID-19 prior to vaccination. Concomitant medication included levothyroxine, metformin and vitamin nos (MULTIVITAMINS). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received her first dose of bnt162b2 (BNT162B2 reported as PFIZER COVID-19 VACCINE; lot number: Ek4176) at vaccination age of 29-year-old via an unspecified route of administration in the left arm on 12Jan2021 16:45 at a single dose for covid-19 immunization but had lump on neck, sore arm, diarrhea starting day 3 through today and sore rib. The patient received the most recent COVID-19 vaccine in a hospital. It was reported that the patient received the first dose on 12Jan2021 and the second dose was on 29Jan2021. On an unspecified date after the second dose, the patient had fever, chills, aches, headache, fatigue, loss of appetite and dulled taste. It was unknown if the patient received treatment for the adverse events and events were considered as non-serious. The adverse events resulted in a doctor or other healthcare professional office/clinic visit. The patient has not been tested for COVID-19 since the vaccination. The outcome of the events was recovering.

sore arm; diarrhea; sore rib; lump on neck; This is a spontaneous report from a contactable consumer. A 29-year-old female patient received the first dose of BNT162B2 (Pfizer-BIONTECH COVID-19 Vaccine; Lot number: Ek4176), via an unspecified route of administration in the left arm on 12Jan2021 at 16:45 as a single dose for COVID-19 immunisation. Medical history included hypothyroidism, PCOS (polycystic ovaries), and allergy to penicillin. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine, was not diagnosed with COVID-19 prior to vaccination, and was not pregnant at the time of vaccination. Concomitant medications included levothyroxine, metformin, and daily multivitamins (also reported as medication that the patient received within two weeks of vaccination). After the first dose, on 15Jan2021, the patient experienced sore arm, diarrhea starting day 3 through today, sore rib, and lump on neck. It was unknown if the events were treated. It was reported that the events resulted in a doctor or other healthcare professional office/clinic visit. Since the vaccination, the patient has not been tested for COVID-19. Outcome of the events was recovering. The case was reported as non-serious (did not result in death, was not life-threatening, did not cause/prolong hospitalization, was not disabling/incapacitating, and did not result to any congenital anomaly/birth defect).

9:50am, client approached nurse 5 minutes post-vaccination complaining of heaviness in her chest, and a swollen tongue. Client was escorted to our emergency area for assessment and observation. History of allergies to nuts, garlic, flax seed, and black pepper. Also history of asthma, and need for epi pens twice in the past. 9:56am pulse 100, O2 100%, BP 150/112, c/o tingling in lips, chest heaviness, and swollen tongue. 10am, Complaints of chest heaviness is worse, no shortness of breath, client is able to talk. 10:10, pulse 93, O2 100%, BP 162/110. Tourniquet placed above vaccine injection site. Medical Director contacted, advised to start with Benadryl based on history and high heart rate. As Benadryl was about to be administered, client increased complaints of chest heaviness, and not being able to swallow. Benadryl (50mg) and Epi (0.3) given at 10:19am. Benadryl was IM in right deltoid, Epi was given in right thigh. 911 called simultaneously. 10:25, O2 100%, pulse 109, reports breathing easier. 10:26 EMS arrived, client transported to local hospital.

Injection site pain, tiredness after 30 minutes, muscle pain in right arm, - joint pain, injection site swelling, nausea, and headache.

Beginning 2 hours after vaccine: Headache/migraine, vice grip feeling in front and side of head and down nose Extreme nausea, overheating, dizziness Overheating gets worse, no fever but inability to cool down even after putting ice on body Nausea worsens, shaking begins with whole body shaking The following day: Diarrhea, fatigue Other symptoms resolved

Extreme dizziness; nausea; It felt like the worst motion sickness all day; Disorientation/Hard time with orientation; This is a spontaneous report from a contactable consumer (patient). A 29-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number and expiry date not reported), via an unspecified route of administration at the left arm on 04Feb2021 09:00 at single dose for COVID-19 immunization. Medical history was none. Concomitant medications were not reported. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient had no allergies to medications, food, or other products. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient has not been tested for COVID-19. On 05Feb2021 09:00, the patient experienced extreme dizziness, nausea, it felt like the worst motion sickness all day, and disorientation/hard time with orientation. No treatment was given as a result of the events. Clinical outcome of the events was recovering. Information on the lot/batch number has been requested.

headache; 9.5hrs after 2nd vaccine dose a fever set in and climbed to 101.2/fever; chills; muscle aches; nausea; This is a spontaneous report from a contactable Other Health Professional reported for herself (patient). A 29-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL3302; expiration date not provided), intramuscular (left arm) on 02Feb2021 13:30 at SINGLE DOSE for covid-19 immunisation. Patient's medical history and concomitant medications were not reported. The patient did not receive any other vaccine within 4 weeks prior to COVID vaccine. Patient is not pregnant. The patient has no other medications received within 2 weeks of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination. Patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL0140; expiration date not provided), intramuscular (left arm) on 13Jan2021 for COVID-19 immunisation. The patient experienced headache, '9.5hrs after the 2nd vaccine dose a fever set in', chills, muscle aches, and nausea all on 02Feb2021 at 23:00. Patient's clinical course is as follows: 9.5hrs after 2nd vaccine dose a fever set in and climbed to 101.2. To accompany the fever were chills, muscle aches, nausea, and a headache. After taking a fever reducer, the nausea stayed and the fever returned approximately 8hrs as did the chills, muscle aches, and headache. It was reported that patient took a fever reducer again and now waiting to see if that helps again. The patient has not been tested for COVID-19 since the vaccination. The patient underwent lab tests and procedures which included body temperature with result of '101.2 (9.5hrs after 2nd vaccine dose a fever set in, and climbed to 101.2)' on 02Feb2021. The patient has not received treatment for headache, chills, muscle aches, and nausea. Facility where the most recent COVID-19 vaccine was administered was reported as 'Workplace clinic'. Outcome of the events was not recovered.

sore arm; fever up to 101.3 (fever dropped to 99 with tylenol, was still at 100 30 hours after injection); full body chills and aches; full body chills and aches; nausea; loss of appetite; 1 instance of vomiting after eating a banana; This is a spontaneous report from a non-contactable healthcare professional. A 29-year-old female patient received second dose of BNT162B2 PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EN5318), via an unspecified route of administration on the right arm on 04Feb2021 08:00 at single dose for COVID-19 immunisation. Medical history included chronic lung illness and sulfa allergy. Patient has unspecified concomitant medication. The patient previously took BNT162B2 on 13Jan2021 first dose (lot number=EL3249) on the right arm; Allergies: CEFZIL, amoxycillin and NEOSPORIN. The patient experienced sore arm, fever up to 101.3 (fever dropped to 99 with TYLENOL, was still at 100, 30 hours after injection), full body chills and aches, nausea, loss of appetite, 1 instance of vomiting after eating a banana on 04Feb2021 04:00. Other events does not received treatment. The outcome of the events were recovered on Feb2021. No follow-up attempts are possible. No further information is expected.

Onset of chills and fever 12 hours after vaccination. Fever worsened throughout that night and reached ~101-102 F. The next morning, approximately 24 hours after vaccination, fever started to improve. That same morning (3/3/21), started having headaches, nausea, fatigue, and chest pain. No medication or treatment was used and symptoms resolved within 24 hours. However, chest pain persisted for about 2-3 days.

Approximately 3 to 4 minutes after receiving vaccine, patient stated she was not feeling good and patient turned red and fainted. She was sitting in chair so mom stood behind her with an ice pack behind neck and holding patient head while dad stood in front of patient. Her body became limp and mom was shaking her body on right side in attempt to wake patient up. Her eyes opened but was still unresponsive and she was breathing heavily for 30-40 seconds. After placing patient on floor and elevating her legs, patient stated she felt better but still fills nauseated. Paramedics were called.

Symptoms: Nauseated and shaking hand Treatment: education, water and snack, had patient wait an extra 15 min. When she left she stated she felt great.

The day after I had major chills, joint pains, nausea, really sore, extreme flu like symptoms. It was a miserable 24 hours, then after I felt like I had about 20 energy drinks and this lasted for about a week.

Persistent toothache (this happened to my brother after the 2nd dose as well) Chills Body aches Nausea

soreness at the injection site (persisted 48 hours after injection), tired (persisted for 24 hours after injection), headache (began approximately 14 hours after injection and persisted for 12 hours), body aches (began 14 hours after injection and persisted for 12 hours), fever (began 14 hours after injection and persisted for approximately 12 hours), chills (began 14 hours after injection and lasted for approximately 6 hours), nausea (began 16 hours after injection and lasted for approximately 12 hours) No treatments were done. No medications were taken at the direction of the vaccine provider who directed that Tylenol should only be taken with a high grade fever in order to promote a full immune response. Mild dehydration 36 hours following injection likely due to nausea decreasing intake of food and liquids.

Immediately following vaccination, started having itchy tongue, ears and mouth. Rash emerged on left chest and shoulder with muscle pain. Left arm became numb, rash at injections site, migraine, numb lips and mouth. Persisted and progressed to vomiting and diarrhea, tachycardia and tachypnea. On 1/14, petechiae around both eyes, widespread muscle and joint pain, tachycardia and tachypnea persist, unable to lift left arm, itchy face, nose and throat. 1/15 Tachycardia persists, migraine, diarrhea, sudden onset vaginal bleeding. 1/16 elevated blood pressure, tachycardia and tachypnea, found unresponsive in bed by my husband and taken to the emergency room.

Rapid Heart Rate - between 120-150bpm for more than 6hrs; diarrhea; This is spontaneous report received from a contactable consumer (patient herself). A 29-year-old female non-pregnant patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, Lot number: EL3248) via an unspecified route of administration on left arm on 14Jan2021 06:45 at Single Dose and then second dose via an unspecified route of administration (lot number: EL3248) on left arm on 03Feb2021 06:45 at Single Dose for COVID-19 immunisation. Medical history included hypothyroidism and COVID. Concomitant medication included levothyroxine and unspecified Birth control (received within two weeks of vaccination). The patient previously took cefaclor (CECLOR), amoxicillin sodium/ clavulanate potassium (AUGMENTIN) and experienced known allergies with both. It was reported that, the patient experienced rapid heart rate between 120-150bpm for more than 6hrs in 2021. Went to the ER (Emergency Room). Beta blocker was given to lower heart rate. This started about 6hrs after vaccine was administered. Also had diarrhea for 3 days after vaccination. The patient had COVID-19 prior to the vaccination. The patient not tested for COVID post vaccination. The outcome of the event diarrhea was recovered in 2021 whereas recovering for another event.

Fever of 101.3 across 24 hours, alternating chills and sweats, severe muscle and joint pain and discomfort, fatigue, nausea, loss of appetite.

Migraine; Nausea; joint pain/specifically in a joint that had a previous injury (not all joints).; This is a spontaneous report from a contactable consumer, the patient A 29-years-old non-pregnant female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: EL3247), via an unspecified route of administration in the left arm on 16Feb2021 at 13:15 (at the age of 29-years-old) as a single dose, for COVID-19 immunisation. Medical history included Osteoarthritis of the knee due to an injury, Known allergies to cats. No concomitant medications. Historical Vaccination includes BNT162B2 Dose 1, lot number=EL3247, administration date=26Jan2021 at 13:15 in the left arm for COVID 19 immunization. No other vaccines were given within 4 weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination the patient had not been tested for COVID-19. On 17Feb2021 at 03:00, The patient experienced Migraine, nausea, and joint pain specifically in a joint that had a previous injury (not all joints). No treatment was given for the events. The clinical outcome of the events migraine, nausea and joint pain was recovering. :

Patient reported history of queasiness after injection. Patient fell weak, diaphoretic after injection. Patient was escorted to a chair when she fainted and became unconscious for approximately 1 minute, had an episode of incontinence. EMS service was ordered. Patient's BP was recorded by the EMS and was hypotensive. Patient refused to go to ER and was escorted to the car where her family member was waiting to take her home.

Upper middle and lower right abdominal pains that were consistent and nothing helped - random spurts of increased pain. 6 days after no relief, I made an appointment with a gastrointestinal doctor. On day 8, I had vomiting and multiple episodes of diarrhea. I saw the doctor on day 9 but there was so much all-over abdominal pain, it was difficult to decipher the cause. A ct scan was ordered but needed authed by the insurance. On day 10 of symptoms with no reflief, I went to the ER. After a ct scan, it was determined that appendicitis was present for probably 10 days which lead to a perforated appendix with abscess and inflammation around the appendix. While admitted to the hospital for 3 days, I was treated with IV antibiotics but the appendix could not be removed due to so much inflammation and abscess. I have a follow up in a few weeks to remove the appendix once another ct scan determines the area is cleared up.

On the first day, a little over 12 hours after the first vaccine, I felt light headed and was nauseous. By noon of that day I had a persistent migraine like headache that remained the entire day and into the next (3/21/2021). On the 3/21/2021 I also experienced dull chest pain and a feeling of tightness throughout the entire day

Patient was administered the vaccine and ask to sit and wait 15 minutes for observation. within 10 minutes of sitting she stated that she wasn't feeling well and was having trouble breathing and swallowing. The pharmacist was notified and an epipen was administered.

29 y/o female presented to hospital with complaints of SOB, skin flares secondary to history of discoid lupus, protracted vomiting, and joint pain. Side effects began 2 days after her 2nd COVID vaccine. Pt was transferred to hospital from another institution due to O2 sat in the 60s (room air), leukocytosis, and AKI. Patient was treated empirically for sepsis/pneumonia as well as lupus flare. She was also initiated on high dose steroids. Possible reaction to vaccine. Chest CT showed diffuse ground-glass opacities and no signs of pulmonary embolism. Pt was transferred from hospital to another facility given progressive organ failure, most specifically liver failure.

Fatigue; Body aches; Fever; Chills; Nausea; vomiting; This is a spontaneous report from a non-contactable healthcare professional, the patient. A 29-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration in the left arm on 20Feb2021 at 08:45 (at the age of 29-year-old) as a single dose for COVID-19 immunization. Medical history included constipation predominant irritable bowel syndrome (IBS-C). The patient did not have any allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medication included ethinylestradiol/ norgestimate (PREVIFEM). The patient previously received the first dose of BNT162b2 on 24Jan2021 at 14:30 (at the age of 29-years old) in the left arm for COVID-19 immunization. On 20Feb2021 20:30, the patient experienced fatigue, body aches, fever, chills, nausea and vomiting. No treatment was received for the adverse events. The clinical outcomes of the fatigue, body aches, fever, chills, nausea and vomiting were resolving. No follow-up attempts are possible; information about batch/lot number cannot be obtained.

High fever, aches, chills, nausea, soreness at injection site, trouble sleeping, headaches, joint pain

Vasovagal Response Confusion, Disorientation, Dizziness, Loss of consciousness, Seizure, Weakness Nausea

fever 99.9/ fever 100.6; chills; sweats; muscle aches; joint aches; fatigue; confusion; migraine; severe nausea; This is a spontaneous report from a non-contactable consumer (patient). This 29-year-old female patient received dose 1 of BNT162B2 (PFIZER BIONTECH COVID-19 MRNA VACCINE; lot number EN6201) via an unspecified route of administration on 15Feb2021 at 13:00 (at the age of 29-years old) as a single dose in the left arm for COVID-19 immunization. Medical history included asthma. The patient was not pregnant at the time of vaccination. The patient had not received any other vaccines within 4 weeks prior to the vaccine. It was unknown if the patient was diagnosed with COVID-19 prior to the vaccine. Concomitant medications included birth control; caffeine, paracetamol (EXCEDRIN), and ibuprofen from unknown dates for unknown indications. The patient previously received acetaminophen in doses over 500 mg and experienced allergy. On 16Feb2021 at 02:00, 13 hours after the vaccine, the patient experienced fever of 99.9, chills, and sweats. Sixteen to twenty-eight hours after the vaccine the patient experienced fever of 100.6, sweats, muscle aches, joint aches, fatigue, confusion, migraine, and severe nausea. The events were reported as non-serious. The patient was not hospitalized for the events. The patient did not receive any treatment for the events. The outcomes of fevers of 99.9 and 100.6, chills, sweats, muscle aches, joint aches, fatigue, confusion, migraine, and severe nausea were recovered. It was also reported that since the vaccine, the patient had not been tested for COVID-19. No follow-up attempts are possible. No further information is expected.

Almost immediately after receiving the vaccine I started feeling numbness in my left arm (injection site), dizzy, nauseous, and experienced tunnel vision. I also started profusely sweating (forehead). I reported my symptoms to the nurse who took my temperature, BP, and heartrate. I had a low grade fever (99 degrees) and slightly elevated BP. I drank water and remained at the site for another 30 minutes and my vitals were checked again before I left.

Immediately after receiving her vaccination, she developed lightheadedness, nausea, and felt like she was having a recurrence of a panic attack. She does have a history of aversion to needles. She was taken to a private section and monitored. Her vital signs are within normal limits. She also developed tingling in bilateral hands. She was monitored and her symptoms resolved.

The day of the vaccine I had horrible body aches and horrible nausea as well that lasted approximately 36 hours. But starting on the 24th so about 11 days post vaccine, my injection site got very red and itchy. The redness then spread down my arm and I developed hives around my elbow. I treated it with a topical Benadryl spray to get rid of the itchiness, and the hives lasted about 36 hours and have already almost faded.

tunnel vision; Nausea; dizziness; feeling weak; headache; metallic taste in mouth; left arm/leg pain; left arm/leg pain; This is a spontaneous report from a contactable consumer (patient). A 29-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose via an unspecified route of administration, administered in Arm Left on 11Mar2021 11:45 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. Medical history included premenstrual dysphoric disorder (Pmdd), major depression (mdd), anxiety, high cholesterol and allergies: Penicillin, all from an unknown date and unknown if ongoing. No COVID prior vaccination and not COVID tested post vaccination. The patient is vaccinated at a clinic. No other vaccine in four weeks. Other medications reported was yes, however unspecified. It was reported that the patient experienced Nausea, dizziness, tunnel vision, feeling weak, headache, metallic taste in mouth, left arm/leg pain all on 12Mar2021. The outcome of the events was not recovered. No treatment for the events. Information on the lot/ batch number has been requested.

The morning after the vaccine, started with dizziness and vertigo, progressed to burning sensation of skin. Felt like "burning from inside out." Went to hospital and was admitted on 4/9. Severe itching, nausea, vertigo. Spent 6 days in hospital. Given doses of steroids, Benadryl, pain medications, gabapentin. Discharged on 4/14. Symptoms have not improved.

cerebral venous sinus thrombosis; CT scan that revealed the clot; horrible headache after intercourse; vomiting; This is a spontaneous report from a contactable consumer (patient). A 29-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EP7534), second dose via an unspecified route of administration, administered in left arm on 25Mar2021 09:45 as single dose for COVID-19 immunisation. Patient was 29 year old at the time of vaccination. Medical history included asthma, gastrooesophageal reflux disease, peanut and treenut allergy, all from an unknown date. Patient had estrogen allergy. Patient was not diagnosed with COVID-19 Prior to or after the vaccination. Concomitant medications included cetirizine hydrochloride (ZYRTEC ALLERGY), medroxyprogesterone acetate (DEPO PROGESTIN), beclometasone dipropionate (QVAR), OMEPRAZOLE, SERTRALINE HYDROCHLORIDE, all taken on an unspecified date and for unknown indication. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient had her first dose of bnt162b2 on 04Mar20210 at 9:45 am in left arm for COVID-19 immunisation. On 28Mar2021 at 09:45 the patient was diagnosed with cerebral venous sinus thrombosis a few days after receiving the second dose of the vaccine. She had a horrible headache after intercourse, went to the ER after vomiting, and had a CT scan that revealed the clot. The patient was hospitalized for cerebral venous sinus thrombosis. The patient underwent lab tests and procedures which included computerised tomogram: revealed the clot. Patient received Heparin and Eliquis as treatment for the events. Outcome of the events was recovering. No follow-up attempts needed. No further information expected.

Nausea; Pain in legs, back and arms; Pain in legs, back and arms; Headache; Low blood pressure; pregnant at the time of vaccination; This is a spontaneous report received from a contactable consumer (patient). A 29-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on 31Mar2021 at 14:30 at single dose for COVID-19 immunization. The relevant medical history was reported as none. Concomitant medications were not reported. The patient experienced nausea, pain in legs, back and arms, headache, low blood pressure on an unspecified date. The patient was pregnant at the time of vaccination. The patient last menstrual period was 15Nov2020. The outcome of the events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

I was diagnosed with acute appendicitis /it did not rupture but it was puss filled; This is a spontaneous report from a contactable consumer patient. A 30-year-old female patient (age at vaccination: 29-years-old) received the first dose of BNT162B2 (Pfizer-BIONTECH COVID-19 Vaccine), via an unspecified route of administration in the left arm on 26Mar2021 at 13:00 (Batch/Lot Number: PAA165969) as a single dose for COVID-19 immunization. The patient's medical history was not reported. The patient was not pregnant, had no other vaccines in four weeks, and did not have COVID prior to vaccination. Concomitant medication included birth control (unspecified; reported as other medication in two weeks). Four days after the patient's vaccine, on 30Mar2021, she was diagnosed with acute appendicitis and had to have it removed. She was told that it did not rupture but it was pus filled. The event resulted in a doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, and hospitalization (for 2 days). The patient underwent lab tests and procedures which included SARS-CoV-2 test (via nasal swab): negative on 30Mar2021. As treatment, the patient's appendix was removed. Outcome of the event was recovering.

fainted five minutes after the vaccination; pale; diaphoretic; vomited; she was extremely anxious about receiving the vaccine; This is a spontaneous report from a contactable nurse. A 29-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, Lot Number: PAA165969, expiry date not reported), intramuscular, administered in left arm on 07Apr2021 10:30 as a single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. It was unknown if patient had known allergies or other medical history. It was unknown if patient had Covid prior vaccination. The patient was not pregnant at the time of the vaccination and report. It was unknown if patient received other vaccine in four weeks and other medications in two weeks. The patient received the vaccine at the doctor's office/urgent care. The patient fainted five minutes after the vaccination on 07Apr2021 10:30. She was pale and diaphoretic. She became responsive within one minute. She was given water and a cold compress, and reported she felt better, but then vomited a small amount of emesis 15 minutes later (07Apr2021). She was evaluated by the physician who determined it was an emotional response to the vaccine. The patient had reported she was extremely anxious about receiving the vaccine (07Apr2021), and had fainted when she tried to give blood, and hadn't eaten anything that day. After sitting for 45 minutes, the doctor felt comfortable letting her leave. A call was placed to the patient at 4:00 pm to check on her. She reported she felt fine. The patient received no treatment for the event vomited, while therapeutic measures were taken as a result of the other reported events. It was unknown if patient was tested for Covid post vaccination. The patient recovered on an unspecified date in 2021 from the events reported.; Sender's Comments: Based on the information available and a close temporal association, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events of syncope. The case will be reassessed once new information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate

chills; fever; nausea; rapid heart rate; body aches; headaches; lose my mental capacity; I was incoherent; threw up; This is a spontaneous report from a contactable consumer (patient). A 29-Year-old female (pregnant: No) patient received 1st dose of BNT162B2 (COVID vaccine, lot number=ER8729) on 11Apr2021 11:45 AM on Left arm for covid-19 immunization. Medical history was hospitalizations for heat exhaustion in 2014 and 2017, Herpes Type 2, covid prior vaccination. No other vaccine in four weeks. Concomitant drugs included Vitamin D, One-A-Day Vitamin. Symptoms started at 12:00 am midnight on 12Apr2021 with chills and fever. The morning of 12Apr2021, symptoms progressed into nausea, rapid heart rate, body aches, headaches, and I started to lose my mental capacity. I didn't know my address when I called an ambulance. When at the hospital, I didn't recognize my wife and forgot my mother's name. I was incoherent. I threw up. I don't remember 7 hours of time from my first day at the hospital. I got a spinal tap to test for meningitis which came back negative. I had an MRV brain scan which came back clear (no blood clots). Hospitalized for 5 days (12Apr2021-16Apr2021). AE resulted in Emergency room/department or urgent care, Hospitalization, Life threatening illness (immediate risk of death from the event). Outcome of the event was recovering. AE treatment was IV fluids, sodium, spinal tap, MRV brain scan. No covid tested post vaccination. No follow-up attempts needed. No further information expected.

Received first dose of COVID vaccine @ 2:08 pm, complained of dizziness, nausea, abdominal pain, sweatiness @ 2:13pm. Placed in zero-gravity chair prior to vaccine due to anxiety with needles. Vital signs assessed, denies shortness of breath. At 2:33 pm, water is given to drink as client reports "abdominal pain is better, nausea going away, no longer sweating." At 2:43 pm, client reports symptoms have resolved, made aware to follow up with primary care. Client leaves observation area, walking with steady gait, at 2:50 pm.

Blood clotting with spotting and pain; Irregular period; Pain in lower left side of abdomen; Blood clotting with spotting and pain; This is a spontaneous report from a contactable consumer (patient). A 29-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on 24Mar2021 10:00 (Batch/Lot number was not reported) as single dose for covid-19 immunization. Facility where the most recent COVID-19 vaccine was administered was Other. Medical history included none. The patient's concomitant medications were none. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine or any other medications the patient received within 2 weeks of vaccination. The patient previously received the first dose on 05Mar2021 08:00 as single dose for covid-19 immunization. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient experienced irregular period after second dose, pain in lower left side of abdomen and blood clotting with spotting and pain on 16Apr2021 12:00. The outcome of the events was unknown. No treatment received for the events. Information related lot/batch number has been requested.

100 degree fever, body aches, sore under arm/armpit of left arm (injection arm), fatigue, nausea, slight headache, swollen lymphnodes

30YO F ICU nurse obesity (BMI 35) COVID 19 on Dec 2 symptoms, Dec 3 tested positive for COVID-19. never hospitalized, outpatient only. 12/12 completed isolation 12/21 received vaccine 12/7 developed Fever chills diarrhea SOB cough Urgent care visit. RLL consolidation on CXR given doxycycline 100 mg po bid worse, fever 40 targetoid lesions to LE (started before doxy) WBC 22K tachycardic tachypneic admitted requiring 2-4L oxygen CT angio without clot, diffuse ground glass and RML dense infiltrate DDimer 7.8 LDH 599 CRP 41 procal 0.67 ferritin 500 Viral respiratory PCR negative Sputum cx with oral flora (pending) COVID ag testing neg COVID PCR 1/3 targets positive (called as indeterminate).

Vaccine given at 7:05am 12:00noon, 5 hours later, I started experiencing severe chest pain, jaw pain and shortness of breath in which EMS was called and I was taken to the hospital. Since then, I lost feeling in my hands and feet, numbness and tingling. I've improved however, during my recovery suffered with spinal pain, shortness of breath, very winded, muscle pain and loss of appetite to especially meat.

I had a sore arm the first couple of days, on the 22nd I had chills sore throat headache congestion sneezing sniffling and low grade fever 99.6. on the 23rd loose stools nasal drainage, I called the hospital hotline and I had to be off for ten days and went to Urgent care and took a rapid test and the test was positive. I have been quarantined for 14 days . The 25th was probably the worst day the 26th was a little better. the 27th symptoms were more mild and I also had diarrhea The 28th I woke up with a headache and light sniffles and the 27th I had no symptoms

Patient began to experience symptoms shortly after vaccination. Pt became flushed and developed red splotches over chest and neck. C/o difficulty swallowing and some GI upset. Began to shake uncontrollably. Initial BP was 149/99 and HR 118. O2 sats at 99%. Administered 25mg of benadryl and monitored patient for approximately 1 hour. After about 30-45 minute, her vitals stabilized at 120/80, Pulse 90, O2 at 100% on room air. D/C'd home at 1:32pm. 24 hours later patient c/o of hives and flushing off and on. Also complained of some GI upset and fatigue. Pt was able to return to work on 1/3/2021.

Redness around the injection site,continued muscle pain at the injection site, warmth and numbness and tingling locally as well. Temperature taken during our call was 99.9 F. She denies hives, dizziness, face or throat swelling or any other signs of allergic reaction. Initially after having the vaccination, she did have some GI upset that resolved after a couple of days.

Body aches; low grade fever; chills, shivering; headache; nausea; stiff/sore arm; stiff/sore arm; This is a spontaneous report from a contactable Other Health Professional for herself. A 30-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot: EJ1685) dose number 1, intramuscularly on 26Dec2020 15:30 at single dose on arm Left for COVID-19 immunization. Medical history included irritable bowel syndrome, chicken allergy and COVID-19. Concomitant medications received within 2 weeks of vaccination included clonazepam, spironolactone and melatonin, all from unknown date for unknown indication. Onset of symptoms began roughly 9hrs post vaccine. Lasted roughly 24 hours (28Dec2020). Body aches, low grade fever, chills, shivering, headache, nausea, stiff/sore arm. Adverse event start date: 27Dec2020 00:00. No treatment was received for the events. The action taken in response to the events for BNT162B2 was not applicable. Outcome of the events was resolved on 28Dec2020.

headache; constipation; This is a spontaneous report from a contactable other HCP. A 30-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EK9231), intramuscular in left arm on 23Dec2020 at a single dose for covid-19 vaccination. The vaccine was administered in the workplace clinic. The patient's medical history and concomitant medications were not reported. The patient had no known allergies. The patient was not pregnant. On 24Dec2020, the patient experienced constipation and headache since vaccine (7 days). The outcome of the events was unknown. There was no treatment for the events. ON 24Dec2020, the patient had COVID test type post vaccination=Nasal Swab with a negative result. The events were assessed as non-serious.

Burning sensation in throat, mild color change in neck and chest- beginning around 8am lasting until about 10am. Uncontrollable tremors, feeling like I need to constantly be moving and tachycardia- started around 830a started to diminish once I took a benadryl around 10a. Headache, fatigue and nausea beginning hours after vaccine, still present on 01/05. Sore arm at injection site and swollen axillary lymph node in same arm.

Lightheaded ness immediately after vaccine About 24 hours later SEVERE diarrhea/urgency. Nausea. Fatigue. Fever 101. Migraine.; Lightheaded ness immediately after vaccine About 24 hours later SEVERE diarrhea/urgency. Nausea. Fatigue. Fever 101. Migraine.; Lightheaded ness immediately after vaccine About 24 hours later SEVERE diarrhea/urgency. Nausea. Fatigue. Fever 101. Migraine.; Lightheaded ness immediately after vaccine About 24 hours later SEVERE diarrhea/urgency. Nausea. Fatigue. Fever 101. Migraine.; Lightheaded ness immediately after vaccine About 24 hours later SEVERE diarrhea/urgency. Nausea. Fatigue. Fever 101. Migraine.; Lightheaded ness immediately after vaccine About 24 hours later SEVERE diarrhea/urgency. Nausea. Fatigue. Fever 101. Migraine.; This is a spontaneous report from a contactable Nurse (the patient). A 30-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number EL0140, expiration date unknown) via an unspecified route of administration on 29Dec2020 at 12:30 PM (at the age of 30-years-old) at an unspecified dose in the right arm for COVID-19 vaccination. The patient's medical history was not reported. No information was reported regarding allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient was not pregnant at the time of vaccination. The patient was administered the vaccine in the hospital. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient answered "yes" when asked to list any other medications she had received within two weeks of vaccination but did not list those medications. The patient stated that she experienced lightheadedness on 29Dec2020 "immediately after vaccine." About twenty-four hours later, on 30Dec2020 at 13:00 she experienced "SEVERE" diarrhea/urgency, nausea, fatigue, fever of 101 and migraine. The patient did not receive any treatment for the events. The clinical outcomes of lightheadedness, severe diarrhea/urgency, nausea, fatigue, fever of 101 and migraine were reported as recovering. The patient underwent lab tests and procedures which included body temperature: 101 on 30Dec2020. It was also reported that since the vaccination the patient had not been tested for COVID-19.

12/26/2020 WOKE UP, STOMACH HURTING, DIARRHEA. MALAISE. CYCLE BETWEEN BOTH, ALL DAY. WENT TO ER SAME DAY; EVENING. COULD NOT GET A STOOL SAMPLE. VITALS WERE GOOD. ADMINISTERED IV FLUIDS. 12/27 STOMACH STILL HURTING BUT NOT AS SEVERE.

12/26/2020 DIARRHEA, MALAISE, SEVERE STOMACH PAINS. WENT TO ER. ADMINISTERED IV FLUIDS. 12/27/2020 STARTED TO FEEL BETTER.

5 days after injection started a light headache. 6 days after injection joint pain, in hips and tailbone. feeling fatigue, nausea. with decreased appetite. Night time of day 6 stomach cramps with diarrhea.

Headache back of neck, twmples and eyebrows, really sore injection site. Fatigue, Malase, nausea off and on, decreased appetite. Feeling dehydrated, chills/ at times painful sensitive skin similar to the flu. Muscle aches throughout the body.

Injection site pain; headache for 2 days; neck and lower back joint pain; neck and lower back joint pain; fever of 101; nausea; chills; neck and lower back joint pain; lethargy; This is a spontaneous report from a contactable Nurse (the patient). A 30-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number EH9899, expiration date unknown), intramuscularly, on 31Dec2020 at 07:30 (at the age of 30-years-old) an unspecified dose in the left arm for COVID-19 vaccination. Medical history included anxiety and depression from unknown dates. The patient did not have any allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient was not pregnant at the time of vaccination. The patient was administered the vaccine in the hospital. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 01Jan2021 at 01:00 the patient experienced vaccination site pain, headache for two days, neck and lower back joint pain, fever of 101 degrees, nausea, chills and lethargy. The patient did not receive any treatment for the events. The clinical outcomes of vaccination site pain, headache for two days, neck and lower back joint pain, fever of 101degrees, nausea, chills and lethargy were reported as recovered. It was also reported that since the vaccination the patient had not been tested for COVID-19.

Pfizer-BioNTech COVID-19 Vaccine EUA Approximately 17 hours post vaccination, I woke with moderate body aches, moderate headache, moderate congestion, mild chills (NO fever), mild nausea, and significant overall fatigue. Symptoms ongoing for 8 hours, however chills and nausea are gone.

Allergic reaction: hives, wilts, redness, itchiness, abdominal pain Treated with Benadryl and went away in 30 min or so

Developed palpitations and tachycardia with sustained HR in low 100?s (baseline is 55). Febrile to 103, chills, rigors, nausea/vomiting.

Fever; aches; fatigue; injection site soreness for 5 days; loss of appetite; This is a spontaneous report from a contactable healthcare professional. A 30-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot/batch number not reported), intramuscular on left arm on 18Dec2020 16:30 at a single dose for Covid-19 immunization. The patient's medical history was not reported. Concomitant medication included birth control medication (unspecified) received within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the Covid vaccine. Prior to vaccination, patient was not diagnosed with Covid-19. On 19Dec2020 at 09:00 AM, patient experienced fever, aches, fatigue, injection site soreness for 5 days and loss of appetite. No treatment was received for the reported adverse events. Since the vaccination, the patient has not been tested for Covid-19. The outcome of the events was recovered. Information about lot/batch number has been requested.

Generalized body aches, malaise, tachycardia, nausea, headache, sweats. Intermittently for 48 hours, worse at night.

Severe flu like symptoms, fever over 101, chills, body aches, headache, nausea/loss of appetite, fatigue, soreness in the arm from injection

BlurredVision NauseaVomiting & Syncope Narrative: 15 minutes after vaccine was given, employee reported visual changes and nausea. Then she lost consciousness for several seconds while seated. Emergency response team was called, no treatment was provided except supportive care and ginger ale when she regained consciousness. She was placed on cardiac monitor and observed for 30 minutes, initial HR was in 50's sinus bradycardia and BP 102/62. No further issues after 30 mins of observation time and employee was released to return to work. Employee reported having a similar reaction after giving blood in past.

Neck pain, chills, high fever, joint pain for 72hrs nausea, abd. cramping (48 hrs post vaccine) persistent symptoms lasting 5 days after COVID vaccine Cervical & submandibular lymph adenopathy

About 12 hours of receiving my second dose I started to get really bad chills. Nothing could keep me warm and I had a fever of 102. I had muscle aches as if I just went through a rigorous workout. I had zero appetite but I?m not sure if that was due to side effects or the fact that I wasn?t feeling well. When I did finally eat something that evening I could barely taste it, I ate it but my taste buds were faintly picking up the flavors. Again I don?t know if it was because of the side effects or the fact that I wasn?t feeling well. The following day, Saturday 01/09/21 I only had chills which would come and go. I did not have fever and my appetite was back. Now today, 01/10/21 I feel my usual self.

About 14 hours post getting the second dose I started having chills and rigor and ended up having a fever of 100.5 degrees fareinheight, took 1 gram Tylenol, fever broke, 4 hours later I had rigor and chills again and was febrile again, and took ibuprofen. I also felt nauseous and have a headache.

Arm soreness- mild, 2 days Headache - mil, 20-60 minutes Diarrhea - mild, 1 day Fatigue - mild, .5 day

At 3 am the next day after my vaccine (sat the 9th)I woke up to all my joints burning, like they were on fire. The next morning I had chills, severe joint pain, fatigue, dizziness, nausea, and rash/ redness on my face (cheeks, nose, forehead). The next day (Sunday, the 10th) I felt much better but still a bit of joint pain and fatigue. Today (Monday the 11th) I felt fatigued, with. A resting heart rate of 90 according to my fitbit. I had some numbness/tingling in my right arm, dizziness, and felt fatigued. Towards the end of today I felt better but still have some pain in lower back and neck.

Strong pain throughout my body. Stronger pain in lower back and neck. Fatigue and tiredness. Stomach malaise

12 hours after vaccination: Uncontrollable Rigors, muscle contractions, fever, chills, hyperesthesia, abdominal pain, nausea, headache, back pain

3-5 mins after receiving, developed tachycardia, shortness of breath, dizziness, and nausea. Improved within 2-3 mins, cleared within 5-10 mins. No further reaction.

Date of symptom onset ? 1/1/21? Symptoms - ? EE reports she began with abd pain, and itchiness to head, face and ear that progressed to generalized hives. EE denies any changes in hygiene products and NKDA or food allergies per EE. Last day of work and shift - ? Home remedies? - EE took Benadryl after onset of symptoms and reported resolution of hives approx. 30 mins after medication. EE reports she spoke with her PCP and scheduled for allergy testing today (1/12) at 1:30 PM. Any improvement? ? yes Recommendation? EE asking if she should get her 2nd dose as scheduled tomorrow. EE encouraged to attend her allergy appointment today and to consult with her MD today for recommendations whether or not to receive 2nd dose. EE provided with HR support phone number if she needs to cancel/reschedule her 2nd vaccine appointment after MD recommendations. EE encouraged to call vaccine support line if she has adverse reactions after 2nd vaccine dose. EE verbalized back understanding and denied further questions at this time.

Nausea; Feeling unwell; 1st dose Pfizer covid vaccine administered on 17Dec2020/second shot of the Pfizer Covid vaccine yesterday (04Jan2021); back pain/back pain was pretty severe and was worse than it would normally be; severe headache that turned into a migraine; severe headache that turned into a migraine; This is a spontaneous report from a contactable consumer. A 30-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EL1284, Expiry Date: Apr2021) intramuscular at left deltoid on 04Jan2021 16:00 at single dose for covid-19 immunisation. 1st dose Pfizer covid vaccine was administered on 17Dec2020 (Lot number: EH9899). She was covid positive the day after receiving her first dose of the Pfizer covid vaccine. Her primary care informed her to get the booster despite testing positive for the virus. She was told since she was asymptomatic that she could get the vaccine. Medical history included back pain, covid from 3 weeks ago (Dec2020). There were no concomitant medications. The patient experienced back pain and severe headache that turned into a migraine on 04Jan2021, nausea and feeling unwell on 05Jan2021. She got the second shot of the Pfizer Covid vaccine yesterday (04Jan2021) around 16:00. Overnight she had back pain, severe headache that turned into a migraine. Now she had developed nausea and was generally feeling unwell. She had covid 3 weeks ago and she was instructed to get the vaccine. She has a history of back pain but states it was obviously triggered. Reports that last night her back pain was pretty severe and was worse than it would normally be. Nausea and feeling unwell was reported as worsened. Back pain was slightly improved. Headache that turned into migraine improved with medication. The outcome of events back pain and severe headache that turned into a migraine was recovering; of events nausea and feeling unwell was not recovered.

Vomiting and inability to eat or retain food, swollen/painful arm lasting 4 days, hard welt/ball like swelling at peak of swelling beginning Thursday evening through Saturday, inability to raise, hold, grasp or use arm for 2 days after injection, consistent fever for 36 hours/intermittent fever through Saturday, tightness in chest (relieved with inhaler every 2 hours) for 36 hours, tingling and phantom pain along left side of body and face, excessive exhaustion, dizziness and unfocused thoughts 48 hours, persistent migraine for 36 hours, intermittent headaches continuing with chills and nausea. Worse symptoms were 24-72 hours after injection, more mild side-effects (intermittent headache, nausea and chills) continuing through today.

1/7/21: Sore arm the night of the vaccine. 1/8/21: Woke-up around 4am with chills. Fever of 101.4 around 7am with generalized malaise and severe fatigue. Spent most of the day in bed. Fevers on and off throughout the day with Tmax of 101.4. Some mild body aches. Sore arm with itching at the injection site. Lump at injection site. Had to call off of work. Loss of appetite. 1/9/21: Afebrile the whole day. Moderate fatigue in the morning. Overall felt better by the afternoon. Sore arm continued with itching and lump remaining at the injection site. 1/10/21: Overall felt better, arm soreness and itching at injection improving. 1/11/21: Mild fatigue. No arm soreness. Itching improved. Lump at injection site improving. Mild body aches in the evening. 1/12/21: Mild fatigue. 1/13/21: No arm soreness, itching and lump at injection site gone.

2 hours after vaccine, felt nausea and aching in neck, like my blood pressure was elevated, hot flashes. stopped after about an hour, returned again in the evening, again lasting about an hour, and did not come back after.

2pm fatigue, soreness in arm 11pm nausea, vomiting, chills 12pm insomnia, fever, chills, body aches, joint pain 2am continued fever despite fever reducers 6am (day after) continued fatigue, arm soreness reduced 12pm continued low grade fever -99.6-100, fatigue 6pm continued low grade fever, fatigue 6am (2 days after) improvement in symptoms 12pm return of low grade fever, and fatigue. continued soreness in arm

Beginning 12 hours after vaccine experienced chills, aches, nausea and headache. Also experiencing pain and swelling at injection site.

I developed mild injection site pain about 5 minutes after the second dose which didn?t happen the first time so quickly. It shortly progressed to a cold/numb sensation from my deltoid down to my finger tips. This persisted but seemed to transition from more numbness to moderate pain from my left scapula, neck and down to my fingers about 7 hours after the vaccine. I also developed intermittent fasiculations of my forearm muscles on the left arm. This morning I woke up with worsening pain, mild numbness but new weakness in the hand and arm. I have a weak grip and can?t fully grab objects. My wrist flexión and extension are also weak as well as shoulder abduction (I am a neurologist by the way so can?t localize it to any nerve distribution). I?m not weak anywhere else and I only have mild arthralgia and diarrhea systemically.

The initial shot wasn't bad. Sore arm within 5 hours. That's all I had, until Thursday evening at 6. Overwhelmed with exhaustion and fatigue. Massive headache coinciding. My arm felt like I had tennis elbow and overall joint pain. Nausea and vomiting through the night. Went to bed about 9:30. Woke up with a fever of 99. Off and on fever and chills through Friday, 72 hours after initial injection. Finally resolved late Friday night.

Patient began feeling dizzy and nauseous about 2 minutes after vaccine administration. She couldn?t stand without falling. 911 was called and she was taken to the nearest hospital

Quickly after receiving vaccine patient began feeling lightheaded/dizzy then progressed to nauseated and feeling the need to vomit. Patients temperature increased slightly to 99.4. Placed a cool washrag on neck and gave Diphenhydramine 25mg at 12:15pm (patient stated had Benadryl at 6am at home before coming to work). Patients blood pressure was taken by parent who is a nurse at Woodridge 122/86. At 12:57pm patients temperature returned to 97.4 and patient was improving. Patients parent gave Zofran for the nausea/vomiting feeling at 1pm. Patient was feeling better but still dizzy and patients parent took the patient home at 1:18pm.

within 15': flushed, nauseated, throat swelling. dizzy., tachycardia Transferred to ED: treated with Benadryl. solumedrol. sx resolved. Observed for 4 hrs. d/cd to home

20 hours after first dose of COVID19 vaccine arm was very sore (normal). Around 2:30am felt pressure and warmth (coming in waves) up towards my chest, lasting 1-2 seconds and occurring about every 5 minutes . Was able to withstand feeling until it became difficult to breath. Lips and face turned white and blue, fainted. Felt extremely nausea when awake. Called 911. Vitals were normal apart from BP was very high 130/100's. EKG was NSR. Blood sugar taken was normal around 113. After 1 hour of event, I took a shower and drank water. I felt the wave one more time before trying to fall asleep. Then stopped. Woke up fine.

Continuing headache and nausea for almost a week after second dose of vaccine. Lasting much longer than other reactions.

Got 2nd dose vaccine at 7:20 am at 5:30 pm I developed chills, went to bed around 8:30 due to not feeling well. I woke up at 10 pm sweeting and body aches. All through the night I was hot then cold. I developed a temperature of 100.8. Had no appetite in the morning. At 7:30 am I started to feel better. Had head ache through out the day Thursday.

Itchiness, hives, wilts, abdominal pain; Itchiness, hives, wilts, abdominal pain; Itchiness, hives, wilts, abdominal pain; Itchiness, hives, wilts, abdominal pain; This is a spontaneous report from a contactable nurse (patient). A 30-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number unknown unable to locate or read the details) via an unspecified route of administration at Left arm on 23Dec2020 14:15 at single dose covid-19 immunization. Facility type vaccine was Hospital. No known allergies and no other medical history. Concomitant medication included ascorbic acid, calcium pantothenate, cyanocobalamin, ergocalciferol, nicotinamide, pyridoxine hydrochloride, retinol palmitate, riboflavin, thiamine mononitrate (PRENATAL VITAMINS), colecalciferol (VITAMIN D). No other vaccine in four weeks. The patient experienced itchiness, hives, wilts, abdominal pain on 01Jan2021 23:45. The events resulted in Doctor or other healthcare professional office/clinic visit. No covid prior vaccination and covid was not tested post vaccination. Treatment Benadryl was received for the events. The outcome of the events was recovered in Jan2021. Information about lot/batch number request.

No reaction noted after first dose. Pt sts woke up on morning after first dose sweating, similarly profuse from past experiences as if he was sick and feverish. Also had "pain" in his throat, a tightness in his chest, and intermittent chills. 14JAN21, condition the same, with worsening in tightness in chest and throat pain. 15JAN21 chest tightness has subsided but throat pain worse, no trouble swallowing. PT sounds congested when speaking. DNS SOB.

Severe dizziness; almost blacked out; Nausea; Elevated heart rate.; This is a spontaneous report from a non-contactable health care professional (patient). A 30-year-old female patient received the first dose of BNT162B2 (also reported as Pfizer-BioNTech COVID-19 mRNA vaccine, lot no: EK5730), via an unspecified route of administration on 08Jan2021 at 08:00 AM at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously took penicillin and experienced allergies. The patient was vaccinated in a hospital. The patient was not administered any other vaccine in four weeks and had no other medications in two weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination the patient has not been tested for COVID-19. It was reported that the patient experienced severe dizziness, almost blacked out, nausea and elevated heart rate on 08Jan2021 at 4:00 PM. The patient did not receive any treatment for the events. The outcome of the events was not recovered. The events were reported to be non-serious.

Wednesday 1/13/2021 I woke up feeling like nauseous, then later in the day I started to get itchy in my lower body that was coming and going (I believe I still had some allegra d in my system). On Thursday 01/14/2021 by noon time the itching had become extreme and unbearable all over my body and felt like my skin was crawling/burning, my chest and parts of my arms were really red . I also developed a lump in my throat that kept getting bigger and felt itchy and couldn't stop clearing my throat. Around 3pm I took 10ml of Claritin. The Claritin had not really helped however the redness had gone down a lot and by 4:30 I was miserable. Informed by a provider I work with to go to urgent care. I arrived at urgent care at about 5:10 where I was treated for an allergy reaction. I was given 0.9% sodium chloride IV bolus 500mL, Methylprednisolone sod suc(PF) (SOLU-Medrol) 125mg Intravenous, Famotidine (Pepcid) 20mg/2ml injection 20mg intravenous, diphenhydramine (Benadryl) 50mg/ml injection 25mg intravenous. The itching subsided within 30 minutes, the itchy throat/ lump was still present but was not getting worse and slowly improving. I was discharged home and was told to pick up famotidine 20mg, otc benadryl and prednisone 50mg to take for 5 days. got home a little after 7 and was able to eat dinner, let dog out, shower, rest before going to bed. I did take another 10 ml of Benadryl at 10:30. Woke up without any itchy skin at 5:45 and was able to return to work this morning. I still have a slight itchy throat but it is tolerable. I took allegra d and famotidine this morning. I am holding off on the prednisone because of the immune response to vaccines from steroids. I don't want to lessen the effectiveness of the vaccine.

severe pain in her lower left side; Abdominal pain that feels like a cramp at first but the pain intensifies when you try to move.; This is a spontaneous report from a contactable health care professional (patient). A 30-year-old female patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine), via an unspecified route of administration on 05Jan2021 at 12:00 on the left arm at a single dose for COVID-19 immunization. The patient had no medical history and no known allergies. The patient was not diagnosed of COVID-19 prior to vaccination. The patient did not have any other vaccines in the last four weeks. The patient's concomitant medications were not reported. The patient experienced severe pain in her lower left side on 07Jan2021. The patient also reported abdominal pain that feels like a cramp at first but the pain intensifies when you try to move on 07Jan2021. The patient did not receive any treatment for the events. The outcome of the events was not recovered. The patient has not been tested for COVID-19 post vaccination. Information about lot and batch number was requested.

Chills, body aches, sweats and nausea began about 8 hours after vaccination. Was received. Symptoms gradually got worse as the day went on. The symptoms we the worst at around the 24hr post vaccine mark. It is now almost 40 hours post vaccine and symptoms have improved but still remain. Symptoms improved with ibuprofen and Tylenol and rest.

Woke up at 3 am with severe chills, went to the bathroom to check temperature. Got incredibly nauseous and light headed. Passed out on the bathroom floor and hit my chin. Had to get stitches, fluid, and CT.

Blacked out; Fainted; Felt very unwell; Nauseous; Chills; Fell; Knocked out, hit her nose, started to bleed; Humongous scar on her nose; In her hand there's a rash with different dots/red; She has petechiae/rash on the forearm; hit her face; knocked out, hit her nose; This is a spontaneous report from a contactable physician. This physician reported that a 30-year-old female patient (daughter) received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 08Jan2021 at single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced blacked out, fainted, felt very unwell, nauseous, chills, fell, knocked out, hit her nose, started to bleed, humongous scar on her nose, in her hand there's a rash with different dots/red, she has petechiae/rash on the forearm, all on an unspecified date in Jan2021. The Caller wanted information on side effects specifically looking at platelet or clotting or bleeding issues. Her daughter, (female, age 29 date of birth) received the 2nd dose of Pfizer vaccine, received it at the (State name), last night. She felt very unwell, nauseous, chills, and then blacked out, fell, knocked out, hit her nose, started to bleed; fainted and hit her face, didn't stop bleeding for 2 hours. There's a humongous scar on her nose. It took 2 hours to stop bleeding. She's going to urgent care today. Her daughter was healthy, yesterday was 2nd dose. In her hand, there's a rash with different dots/red. She has petechiae/rash on the forearm. Thankfully it (bleeding) did stop. The outcome of events for 'knocked out, hit her nose, started to bleed' was resolved on an unspecified date, for other events was unknown. The case was reported as non-serious. Information on the Batch/Lot number has been requested.; Sender's Comments: Based solely on a chronological association a causal relationship between events blacked out and fainted and BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), cannot be completely excluded. The case will be reevaluated should additional information become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.

Starting the night after the vaccination Jan. 7 the patient woke up with a fever of 100.2 and also arm soreness, body aches and headache. Patient temperature spiked to 101.2 at 9pm that evening. Jan 9 patient temperature was 100.5 at 3pm and patient noticed some stuffiness in the nose. Jan 10 temperature 99.5. Jan 11 3am temperature of 101.3, stuffy nose, cough, body aches, headache, nausea. Jan 12 temperature of 102.8 with Rigors. Jan 13 still having headaches, on and off nausea, cough, low grade fever 99.2. Jan 14 Temperature 100.9. Jan 15 Temperature 101.8. Patient continues to have fever every evening.

injection site soreness, Headache, Fever, nausea, muscle soreness, joint pain, shaking/ shivering took 1 Tylenol at 2:15 am. woke up at 3:23 am to bout of SVT 154 and tachycardia for a few hours after.

Shortly after the vaccine I started having a migraine and extreme light sensitivity. Today I have gradually become nauseated, have a poor appetite, feel very lethargic, and have a mildly sore arm.

Within 5 mins of injection tingling between shoulder blades and face, came in waves. Within 20 mins of the injection throat tightness, dysphagia. 50mg Benadryl PO, 20mg Pepcid PO, 2 puffs of Albuterol. Throat tightness resolved within the following 30 mins. The next day body aches, itching of arms, and swelling in the left axilla (same side as injection). 48 hours after injection rash and itching on the upper back, chest, and both arms resolved with 50mg Benadryl.

chills and rigor; fever/febrile; headache; nausea; whole body muscle aches; This is a spontaneous report from a non-contactable nurse (patient). A 30-year-old adult female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: Ej1686), via an unspecified route of administration on 10Jan2021 10:30 AM at single dose on the left arm for COVID-19 immunisation. The patient is not pregnant at the of report. COVID-19 vaccine was administered in the hospital. Medical history included migraine, Polycystic ovarian syndrome (Pcos), seasonal allergies, penicillin and sulfa antibiotics allergies. Concomitant medications (Other medications in two weeks) included levothyroxine sodium (SYNTHROID), spironolactone, montelukast sodium (SINGULAIR), loratadine (CLARITIN [LORATADINE]) and calcium levomefolate (DEPLIN). The patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: Ej1685) on 21Dec2020 03:15 PM on the left arm. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient was not diagnosed with COVID-19 prior vaccination. The patient reported that on 11Jan2021 12:00 AM, 14 hours post receiving the second dose, she had chills and rigor and ended up with a fever. Patient took Tylenol, fever broke and 4 hours later again had chills and rigor febrile again and took ibuprofen. The patient also had headache, nausea, and whole body muscle aches. The events were assessed as non-serious. Outcome of the events was recovering. The patient has not been tested for COVID-19 since the vaccination. No follow-up attempts are possible. No further information is expected.

DAY OF VACCINE: SORENESS AT INJECTION SITE MORNING AFTER VACCINE (1/12): BODY ACHES, CHILLS, MILD HEADACHE, FATIGUE, INTENSE SORENESS AT INJECTION SITE/ AFTERNOON & NIGHT (1/12): MORE FATIGUE AND SOME NAUSEA. 2ND MORNING AFTER VACCINE (1/13): SOME FATIGUE AND LIGHT NAUSEA. 2ND AFTERNOON AFTER VACCINE (1/13): NO SYMPTOMS. TOOK TYLENOL (EXTRA STRENGTH) & ADVIL.

Systemic: Exhaustion-Mild, Systemic: Nausea-Severe, Systemic: Rise in BP, Dizziness, Kidney Pain-Medium

~12h after vaccine administration, severe body aches, fever, fatigue, malaise, nausea and vomiting lasting ~18h.

2200 - headache 2230 - headache worsens, nausea 2300 - headache + vomiting + chills, afebrile 2330 - Tylenol 1000mg 0100 - woke up with body aches, chills, headache 0300 - body aches worsen, nausea returns 0730 - body aches, armpits very tender, headache 0800 - Tylenol 1000 mg 0900-2200 fatigue, body aches, armpits tender, neck tender, headache 2200 - Tylenol 500mg, sleep 0500 - minor joint pain, minor armpit pain 0600 - Tylenol 500mg 0600-2200 - pain resolves

7:25 PM pt not feeling well, nausea, BP: 136/84, HR: 84, gave juice and monitored, rest, cool wash cloth 7:35 PM pt laid on floor, dry heaving, BP: 116/87, no respiratory distress, slight dizziness, continued to monitor, provide comfort, water, sprite 7:54PM pt feeling better, BP:130/84, HR: 88, pt requested to go home and felt safe driving 8:10 PM pt called to confirm she arrived at home

Arm soreness started evening on 1/20/21. At 1:30AM 1/21/2021 I woke with a fever, chills, muscle pain, joint pain, muscle cramps, headache, nausea and fatigue. Highest fever 102.3, fever holding at 100.5 with Tylenol. Drinking fluids.

Nausea; Muscle aches; General unwell; Anxiety; Body feels heavy and hard to move; Body feels heavy and hard to move; Arm where injected is very uncomfortable; This is a spontaneous report from a contactable nurse (patient). A 30-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3248), via an unspecified route of administration on 12Jan2021 at a single dose on left arm for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously took the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: Zk5730), via an unspecified route of administration on 22Dec2020 at a single dose on left arm for COVID-19 immunization (at 29 years old). The patient experienced nausea, Muscle aches, General unwell, Anxiety, Body feels heavy and hard to move around, Arm where injected is very uncomfortable on 13Jan2021 01:30 AM. The outcome of the events was recovering. The events were assessed as non-serious. The patient was not pregnant at the time of vaccination. Facility where the most recent COVID-19 vaccine was administered was Hospital. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.

Severe body aches especially neck and back pain, nausea/vomiting, severe headache unrelieved by over-the-counter medication, light sensitivity, fatigue, severe injection-site pain, chills with low-grade fever (99.8F). Symptoms listed began approximately 18 hours after 2nd COVID-19 vaccine was given and lasted until 48 hours after vaccine was administered.

body aches; fevers; nausea; This is Spontaneous report from a contactable consumer. A 30-year-old female patient received second dose BNT162B2, via an unspecified route of administration on 07Jan2021 at the 30 years old at single dose for COVID-19 immunization. The medical history and concomitant medications were not reported. The Historical Vaccine included BNT162B2 for COVID-19 immunization (dose number 1). The patient was a nurse and she and several of her colleagues received the second dose of COVID-19 vaccine on Thursday 07Jan2021. On Friday 08Jan2021, she and many of her colleagues woke up with body aches, fevers, and nausea. She said the side effects went away within 12- 24 hours. There was no treatment received for all the adverse events. The outcome of the event was recovered in Jan2021. Information on lot/batch number has been requested.

1/13 at 3 am started experiencing severe nausea/vomiting, severe diarrhea, severe body chills and aches, severe migraine and fever of 101.2F. Continued through 1/14 and missed work. Returned to work on 1/15 still having fatigue, nausea and severe headache.

Headache about 3 hours after injection. Nausea 8 hours later. Extreme fatigue about 24 hours later. Pain and swollen lymph node under arm pit at 24 hours last around 72 hours. Vaccinated on right arm

Within one day of getting vaccine: dizziness, severe body aches, chills, 101.5 fever, mild headache. Symptoms persisted two days after the vaccine. Three days after vaccine: severe abdominal cramps and diarrhea. Fours days after vaccine: severe headache.

extremely decreased blood flow (temperature) in extremities. Core far above normal temperature ( normally 96.8, currently 100.8). Sweating. Shaking due to cold extremities. Migraine. Pain in lower back (kidney area), chronic and achey. Joint pain in legs/ hips. Nausea constantly. Feeling of overall pain and discomfort. exhaustion.

24 hours after taking the second covid dose I felt weak and nauseous and was having chills then diarrhea 48 hours not sure if its the vaccine but I thought it?s good to report it I just took motrin and felt relief

Felt chills, myalgia, malaise, nausea, GI disturbances in intestines (rumbling), bad headache (these have all lasted for about 24 hours so far

Within 30 minutes of injection, headache occurred that lasted approx 6 hours reported that was similar to first injection. Approx 2 hours after administration mild nausea that lasted approx 3 hours. At approx 16 hours after injection, headache again reported with elevated HR (approx 20 bpm above normal resting average), nausea, and muscle aches that lasted approx 3 hours. 24 hours after injection, low grade fever with muscle aches, chills, headache, and nasal congestion that lasted approx 5 hrs.

Within 5-6 hours of getting the vaccine, began having severe abdominal pain at the top of my stomach. Felt like severe hunger pains but got worse when I ate.

High anion gap metabolic acidosis. Patient developed poor appetite, nausea, and vomiting. She was unable to tolerate oral intake. She presented to the emergency department after two days of vomiting and was found to have high anion gap metabolic acidosis with pH of 7.0 requiring ICU stay. She had no prior hx of diabetes and was noted to be euglycemic. Patient's acidosis resolved after IVF resuscitation.

Sore arm for 24 hours after initial vaccination. I am breastfeeding and starting on day 7 after vaccination my breastfed infant had diarrhea and fevers for a few days, and continues to have diarrhea without fevers despite not making any other changes in diet, etc.

Approximately 12:05 patient was waiting in observation area and started reported to RN that she was feeling shaky. She was taken to private room where she could lay down and be monitored. Given 8oz of water that she consumed over the next 10 minutes. 1210 employee reported feeling shaky and nauseated. BP122/72 HR 92 O2 100 R 18. 1215 employee reports feeling lightheaded and is reclined back on bed. 1220 BP110/80 HR 119 R 18 O2 100. Employee stated shakiness had resolved but had difficulty articulating progression of current symptoms. 1225 employee states lightheadedness and nausea have improved and she would like to sit in a chair instead of bed. Given another 8oz of water which she consumed. RN assisted employee to chair and she sat until 1235 and then was escorted to car by another RN and drove home. Advised that if symptoms returned or new symptoms occurred to seek medical attention by either her PCP or the ER depending on severity. Employee states she had eaten breakfast and denied snacks offered. Employee reports history of allergies and that she carries rescue meds. No meds given during this incident.

Approximately 4 hours after vaccination Pt began with epigastric abdominal pain and persistent diarrhea, unable to tolerate liquids or food PO since that time without vomiting or episode of diarrhea within a few minutes.

First vaccine chills and feverish but did not have a fever. Headache, nausea, joint pain, Body aches , runny nose, brain fog, fatigue and swollen lymph nodes . 2 days after the first vaccine. Second vaccine chills, feverish, runny nose, head ache and body aches, fatigue and feels like she is going to have swelling in the lymph nodes again.

Patient c/o metallic taste, chest tightness, SOB, difficulty breathing, and difficulty swallowing. Also had a mild erythematous rash. Symptoms began < 5 minutes after vaccination. Epi Pen was administered and code team took patient to the emergency room. In the emergency room the patient was treated with benadryl (50mg PO once), prednisone (60mg PO once), famotidine (20mg PO once)and monitored for 4 hours. Symptoms improved and patient was discharged home safely.

Lymph node in my right armpit was swollen; Diarrhea; Exhausted/Still tired; Headache/ My head and body still hurt; Felt sick; Broke out in hives all over my body; Extreme pain in my right arm, upper right side of my back and under my right breast; Extreme pain in my right arm, upper right side of my back and under my right breast; Extreme pain under my right breast/body still hurt; This is a spontaneous report from a contactable consumer (patient). A 30-year-old female patient receive the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number not available), via an unspecified route of administration on 12Jan2021 13:00 at single dose in right arm for COVID-19 immunization. Medical history included the patient had known allergies to Erythromycin and pineapple. The patient had Covid-19 prior vaccination on an unspecified date. The patient had other concomitant medications. On 12Jan2021 14:00, 1 hour after vaccine the patient broke out in hives all over her body. The patient went to the ER at around 2-3pm. Later that night the patient had extreme pain in her right arm, upper right side of her back and under her right breast. The patient called ER and they told the patient to monitor it. The next morning on 13Jan2021 the patient was exhausted, had a headache and felt sick. Her right arm was painful to touch or lay on. The hives went down some. On 14Jan2021 the patient woke at 7am and her lymph node in her right armpit was swollen. It's painful to lower her arm due to the swelling. The patient was still tired and now the patient had diarrhea (on 14Jan2021). The patient's hives were less noticeable today. Her head and body still hurt. The patient had been on bed rest. No treatment was received for the events. The outcome of the events was reported as recovered with lasting effects in Jan2021. Information on the lot/batch number has been requested.

On Monday, January 25, 2021, at 11:40am I received the second dose of a series for the Pfizer COVID-19 vaccine. Over the course of the rest of that day, I began to develop a headache and mild neck soreness. That night, I slept poorly. When I awoke just before 5:00am the next day, Tuesday, January 26, I did not feel well. I was experiencing headache, malaise, nausea, myalgia, arthralgia, and low-grade fever. I called my supervisor around 5:30am that day and we decided it was best that I stay home to recuperate. Throughout the day, I mostly rested and slept, took Tylenol, and began to feel better in the mid-afternoon. I did call and leave a voicemail for hospital Employee Health around 1:30pm on Tuesday the 26th, but did not hear back. Today, Wednesday, January 27, I am feeling much better, and well enough to come to work.

Patient experienced a mild reaction with first Covid vaccine and upon second vaccine administration, patient experienced numbness in ear and jaw, hives, nausea, dizziness, and tachycardic. Patient was seen in the emergency department given diphenhydramine 50 mg, famotidine 20 mg, ondansetron 4 mg, and 1L of sodium chloride. Patient was monitored, EKG normal, and then discharged.

Symptoms s/p 2nd dose of Pfizer vaccine. Moderate to severe headache, nausea, body/joint aches and pain, and generalized fatigue resulting in inability to work the day after dose given. Fatigue started around 20:00 on 1/5/2021 (same date as 2nd dose administration), with increasing discomfort throughout the night. Symptoms continued until about 1:00 on 1/7/2021. Peak symptoms 1:00am-12:00pm on 1/6/2021.

chills, stomach upset, and muscle aches within 24 hours of administration. Symptoms resolved without intervention.

I did not feel the shot going in, so much so that I wished I had looked to see if I was actually vaccinated. About 6 hrs after vaccine, I felt soreness at the injection site, very similar to the flu vaccine. About 12Hours post vaccine, my arm was so sore I could not lift it. That night I took two Tylenol and had to wrap my arm in a heating pad. I woke up around 3am that following morning with a fever of 104 F. I was so dizzy from the high fever. I felt extremely nauseated. My body ached mostly in my legs and lower back. It hurt to sit on the toilet, to put on clothes. My Fevers happened at night time ranging from 102-104F for 4 days. My injection site soreness lasted for 7 days. Body aches lasted around 2-3 days. Dizziness subsided after my fever broke, but was replaced with a severe headache lasting 2 days.

Patient received Pfizer vaccine #2 today. After the vaccine, the employee reported the following symptoms: dizziness burning sensation in the right side of her neck and r ear Lot: EL 3247 Time of Administration: 1:10pm in LEFT arm Time Symptoms Began: 1:40pm when she stood up. Felt a rush and then got dizzy She was given a pink card-dizziness and numbness in legs after last vaccine. For the next few days, she had intermittent dizzyness, nausea, extremely tired _____ Patient alerted observer who took the patient to the medical observation area. I was alerted and responded. She was sitting on the couch in the observation room. Initial Assessment @ _1:42om_: Patient is Patient is AAO. The employee is sitting up on the sofa. The employee is pink and does not appear to be in distress. She is talking and making conversation. She was given a Ginger Ale. We made convsersation for the next ~10 minutes. She was in no distress at all. Vitals @: 155pm HR: 79 BP: -- O2: 98 Employee was discharged without treatment. The RN was notified for follow up. Patient wil call us if anything progresses.

Post covid vaccine administration, while sitting for 10 minute time frame, complained of numbness and tingling in mouth and tongue. States she is allergic to apples and avacodos and this is the type of reaction she normally has after eating this type of food. Patient evaluated by facilitator. No difficulty breathing or shortness of breath noted, patient not in distress. Numbness and tinging continued past 10 minutes observation time not improving. ERT called to evaluate patient. No distress noted. Taken to pharmacy and received oral diphenhydramine. Sitting in clinic for additional time frame - total approximately 70 minutes post vaccine. Complaints of feeling some nausea. No distress again noted. Continues to complain of tingling and numbness in mouth and tongue at 1800 which is approximately 40 minutes post medication. Additionally complaints of feeling more numbness around mouth. VS taken: T - 37.1, P - 68, BP - 128/80, R- 18, pulse ox - 100%. No difficulty breathing. States situation unchanged from previous. ERT notified again. Patient evaluated by team. Options discussed with patient by team nurse - can be seen in ED or go home and take additional dose of antihistamine in 4 hrs from time of first dose. Encouraged to get a ride home and leave car at hospital. Husband called by patient. Waiting for ride. Encouraged to seek additional medical care if not feeling improved after 2nd dose of medication at home. Also encouraged to discuss 2nd vaccine dose with PCP prior to taking 2nd dose. Discussed with patient to utilize vaccine app to document post vaccine effects. Escorted to hospital lobby for ride at 1830.

Scratchy throat ("feels like something sharp stuck in my throat"), vomiting (2/2 throat sensation), lightheadedness 1g Tylenol PO and 12 hours of sleep lead to resolution of symptoms

Aches, severe headache, fever over 101.1, loss of appetite, overall malaise, injection site swelling and pain for four days

I became nauseous and having body chills for 4-5 hours with 1 episode of vomiting. I then had a sustained headache with nausea until 8:00 am on 1/27/2021.

Burning sensation entire arm of injection site - started roughly four hours after injection. Extremely nauseous for several days. Strong headache and fatigue. Shingles outbreak a week later on the same side as injection, lower left leg.

Fever; chills; Restlessness; fatigue; constant headache; Periodic chest pain that radiates to upper abdomen and up on ears and neck and radiate to back; Periodic chest pain that radiates to upper abdomen and up on ears and neck and radiate to back; Periodic chest pain that radiates to upper abdomen and up on ears and neck and radiate to back; Periodic chest pain that radiates to upper abdomen and up on ears and neck and radiate to back; Periodic chest pain that radiates to upper abdomen and up on ears and neck and radiate to back; This is a spontaneous report from a contactable healthcare professional reporting for self. This 30-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number= EL 3302) on 17Jan2021 08:45 AM (vaccine location= Left arm) at single dose for Covid-19 immunisation. Medical history and concomitant medications were not reported. The patient previously received first dose of BNT162B2 (lot number= EL1284) on 27Dec2020 09:15 AM (vaccine location= Left arm) at single dose for Covid-19 immunisation. Patient did not have other vaccine in four weeks, and did not have other medications in two weeks. No known allergies. Patient was not pregnant. The patient experienced fever and chills approximately 11 hours after vaccine. Restlessness, fatigue and constant headache. Periodic chest pain that radiates to upper abdomen and up on ears and neck and radiate to back. Fever went away about 16 hours after fever onset and was coming back approximately 36 hours after vaccine dose. The events onset date was reported as 17Jan2021 08:00 PM. No treatment received. Patient did not have COVID prior vaccination, did not test COVID post vaccination. Outcome of events was recovering.

Excessive vomiting for 24 hours; Excessive nausea for 24 hours; patient was pregnant at the time of the Covid-19 immunization; patient was pregnant at the time of the Covid-19 immunization; patient was pregnant at the time of the Covid-19 immunization; This is a spontaneous report from a contactable healthcare professional (patient). This healthcare professional reported information for mother. This is maternal report. A 30-year-old pregnant female patient receive bnt162b2 (BNT162B2 reported as PFIZER COVID-19 VACCINE; lot number: EJ1686; expiration date: unknown), via an unspecified route of administration on 18Jan2021 at a single dose for covid-19 immunization. Medical history included had COVID prior vaccination. The patient has no known allergies. The patient's concomitant medications were not reported. The patient received her vaccination in a nursing home/senior living facility. The patient was pregnant at the time of the Covid-19 immunization. The patient reported experiencing excessive nausea and vomiting for 24 hours (unspecified date). The patient received treatment for the adverse events which included over the counter medications. The patient was not COVID tested post vaccination. The outcome of the events nausea and vomiting was recovering while the outcome of the other events was unknown.

I received the Pfizer vaccine on January 11th, 2021. On January 12th,2021 I experienced nausea, severe body aches, chills, sweating, a severe headache and fatigue. Symptoms lasted about 24 hours. I had some axillary tenderness (I had this with the first vaccine as well) this lasted about a week. I also had some moderate bleeding at injection site after the vaccine was given. it resolved quickly. I took Tylenol and ibuprofen for the headache and body aches.

My first reaction after the second dose of Pfizer vaccine was numb right arm immediately after the injection. This was followed by a feeling of shakiness and cold sweating. After about 20 minutes my heart started racing and hives/rash on neck and chest. After about 30 minutes of observation I was told to go straight to urgent care. I went to Accelerated Urgent Care. I received a shot of I believe Dexamethasone and was prescribed prednisone. Throughout the weekend following the injection on Friday I have felt tired and have had moderate diarrhea and feelings of being flushed.

8am: fatigue, sore arm. 12pm: extreme fatigue, really sore arm, fever. 4pm: extreme fatigue, really sore arm, fever, nausea. 8pm: extreme fatigue, really sore arm, fever, nausea, headache. 8am 1/21: totally fine.

Patient received 0.3mL second dose of Pfizer COVID-19 vaccine. Lot number above. 11:55 immunization 12:00 patient states she feels "shaky". take to observation room where rescue meds available. 12:05 patient reports lightheadedness. Given 8 oz of water which she took orally. 12:10 patient feels nauseous. BP 122/72 P 92 O2 100% Resp 18 12:15 patient reports she is more lightheaded/dizzy. She is reclined on bed and uses her phone to text her significant other. 12:20 patient reports symptoms are improving. Given another 8 oz of water which she took orally. Reports she did eat breakfast this day, but not lunch. No meds taken. 12:25 patient reports she is feeling better and sits up. BP 110/80 12:30 patient taken to lounge chair and on her phone. 12:40 patient reports all symptoms have resolved and she would like to leave. She is escorted to her car by RN and advised to call PCP or go to ER with any new or returning symptoms. Voices understanding.

Patient reports she felt hot, dizzy and nauseated. She did have a syncopal episode which she has had in the past during stressful experiences. She reports some chest tightness. Patient was transferred via EMS to hospital after being given Zofran 4mg IVP for nausea. She was administered Decadron 8mg IVP at the hospital along with K-tab 20mEq for hypokalemia. She was released and stated she felt better.

Patient complained of feeling flushed, sweaty, and nauseated. She was given water and laid down. Vital signs: BP 120/77, HR 89, O2 99% on room air. Monitored for additional 20 minutes and patient's symptoms resolved.

Pfizer-BioNTech. I suffered from chills, headache, joint and muscle aches, and nausea. The symptoms were severe from 7:30 pm on Monday, the day of the dose (vaccine received at 9:30AM), until 5:30 PM Tuesday (approximately 22 hours). The symptoms were relieved by taking extra strength tylenol every 4 hours. The symptoms were lessened, but still present until 9:30 AM on Wednesday. I was still suffering from a minor headache all day Thursday. I also had soreness in the injection site, there was no swelling or redness that I noticed; the soreness was mostly gone by Thursday. I have had a left eyelid twitch in the past (randomly), it returned after the vaccine and was very bothersome. Today is Thursday and the eyelid twitch is still bothering me.

Received initial COVID vaccine at about 1200 today. About ten minutes later started to feeling burning CP, SOB, feeling of tongue swelling, and had a loose stool. Now feeling lightheaded. Was feeling fine prior to the immunization. Anxiety. Anaphylaxis. 30 yo female known hx of allergic reaction/atopy to vaccines presented with anaphylaxis approx 10 minutes after the covid-19 Pfizer vaccine.